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| ID | Type | Description | Link |
|---|---|---|---|
| F13114002 | Other Identifier | UAB Institutional Reveiw Board |
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| Name | Class |
|---|---|
| Grifols Biologicals, LLC | INDUSTRY |
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The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities).
The intense post-CPB systemic inflammatory response syndrome (SIRS) is well described in neonates and infants. Increased production and release of pro-inflammatory cytokines, including Tumor Necrosis Factor, Interleukin1-B, and Interleukin-6 may suppress myocardial contractility, induce capillary leak, and activate complement and the clotting cascade - together leading to potential organ injury and death. SIRS is also frequently accompanied by impairment of the humoral immune response. One potential reason for this acquired immunodeficiency after cardiac surgery is the removal of immunoglobulins (Ig)s from the vascular space into other compartments where they are either sequestered or lost from the body altogether. We recently demonstrated that such Ig depletion from the intravascular compartment occurs in neonates following cardiac surgery. In a retrospective study of 53 children <3 months of age, we showed that plasma Immunoglobulin G (IgG) concentration drops precipitously after cardiac surgery and does not return to preoperative levels by 7 days; 51% of patients had hypogammaglobulinemia.
An important question is whether post-CPB low IgG has clinical consequence. IgG plays an essential role in the humoral immune system, activating complement and inducing the phagocytic system to neutralize pathogens. IgG deficiency is a known risk factor for infections in other pediatric populations. We were the first to demonstrate that post-CPB hypogammaglobulinemia is associated with worse clinical outcomes, including increased secondary infections (37% vs.12% in those without low IgG, p<0.05). These novel findings are paramount in that they identify a potential modifiable risk factor to improve outcomes after pediatric cardiac surgery with CPB. Additionally, low IgG is accompanied by fluid overload and prolonged mechanical ventilation. Igs constitute an important component of plasma oncotic pressure, so hypogammaglobulinemia may exacerbate anasarca, prolonging postoperative convalescence and increasing the morbidities associated with increased ICU length of stay.9
Igs have an increasingly recognized role in modulating the innate immune response. Present use of IVIG exceeds mere antibody replacement and extends to the treatment of autoimmune and inflammatory conditions. In fact, more than 75% of IVIG use in the U.S. today is for the treatment of inflammatory conditions, where proposed mechanisms include reduction of pro-inflammatory cytokine and adhesion molecule expression, superantigen neutralization, restoration of glucocorticoid responsiveness, and blockade of complement fragment deposition. It is plausible that IVIG could benefit neonates after cardiac surgery not only via restoration of humoral opsonization capacity, but also as a modulator of innate immunity and SIRS. According to this model, tissue injury, CPB, and shock trigger SIRS, leading to hypogammaglobulinemia and resultant increased susceptibility to inflammatory dysregulation which might be ameliorated via administration of IVIG.
In an adult study, IVIG failed to benefit postoperative cardiac patients with severe SIRS. However, the dose of IVIG given was relatively small compared with that typically given for autoimmune and inflammatory conditions. Neonates and infants may be more susceptible to the harmful effects of acquired hypogammaglobulinemia than adults as they may be unable to generate adequate quantities of antibodies in response to pathogens, relying mainly on maternal Igs until around the 4th to 6th month of life. In addition, they display an exaggerated inflammatory response to CPB as compared with older children and adults, so they might stand to benefit more from IVIG as an immunomodulator.
Because of the increased vulnerability to acquired infection and other morbidities in the setting of hypogammaglobulinemia as result of enhanced SIRS and immune dysfunction, it is feasible that normalization of IgG concentration in the neonatal and infant population may improve clinical outcomes via restoration of the humoral immune system, modulation of the innate immune system, and restoration of intravascular oncotic pressure. The appropriate IgG level threshold for treatment and optimal plasma IgG level to target after administration of IVIG are presently unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG | Experimental | Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose and will be administered per hospital standards for IVIG administration. |
|
| Normal Saline | Placebo Comparator | Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. This infusion will be administered as if the subject is receiving IVIG according to hospital policy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Drug | Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Infections | The primary endpoint of this study is incidence of post-operative infections through hospital discharge | until Hospital Discharge, an average of 30 days |
| Post-operative Infection | Any positive culture or treatment for culture negative sepsis within 1 week of surgery | within 1 week of surgery |
| Blood Stream Infection | Any positive blood culture during the post-operative period until hospital discharge | until Hospital Discharge, an average of 30 days |
| Blood Stream Infection Within 1 Week of Surgery | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Plasma Albumin | Plasma albumin will be assessed at 24 and 48 hours. | up to 48 hours post CPB |
| Fluid Overload Variables | The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Alten, MD | University of Alabama at Birmingham Pediatric Cardiac Critical Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States |
IPD will not be shared with other individuals
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| ID | Title | Description |
|---|---|---|
| FG000 | IVIG | Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. |
| FG001 | Normal Saline | Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVIG | Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-Operative Infections | The primary endpoint of this study is incidence of post-operative infections through hospital discharge | Posted | Number | subjects | until Hospital Discharge, an average of 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVIG | Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose. IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Alten, MD | UAB Pediatric Cardiac Critical Care Medicine | (205) 975-3123 | jalten@peds.uab.edu |
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| ID | Term |
|---|---|
| D000361 | Agammaglobulinemia |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Placebo | Other | If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. |
|
|
| 0-24 hours post-CPB |
| Post-operative Inotrope Score | The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a "normal" scale or range used for this calculation. | first 48 hours post-CPB |
| Respiratory Variables | Alive, ventilator free days will be recorded at hospital discharge. | until Hospital Discharge, an average of 30 days |
| Hospital Discharge | From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days. | Approximately 1 month |
| Plasma Immunoglobulins | Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op | 5 days post-op |
| Interferon-gamma Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | Pre-operative to 48 hours post-operative |
| Immunoglobulin Concentration in Chest Tube Drainage | Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative. | 24 hours post-op |
| Mortality | Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge . | Approximately 1 month |
| Intensive Care Unit Length of Stay | The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0. | 1 month |
| Fluid Overload Variables | The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg. | 0-48 hours post-CPB |
| Respiratory Variables | Time until first extubation in hours | until extubation, an average of 2 days |
| Respiratory Variables | Total time duration of post-operative length of mechanical ventilation until hospital discharge | until extubation, an average of 2 days |
| Interleukin-10 Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | pre-operative through 48 hours post-operative |
| Interleukin-12p70 Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | pre-operative through 48 hours post-operative |
| Interleukin-1b Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | pre-operative through 48 hours post-operative |
| Interleukin-6 Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | pre-operative through 48 hours post-operative |
| Interleukin-8 Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | pre-operative through 48 hours post-operative |
| Tumor Necrosis Factor Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | pre-operative through 48 hours post-operative |
| Immunoglobulin Concentration in Peritoneal Dialysis Drainage | Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative. | 24 hours post-op |
| Serum Creatinine | Pre-operative and 48 hour post-operative maximum creatinine recorded. | 48 hours |
| Lactic Acid | pre-operative through 24 hours post-operative |
| Normal Saline |
Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| Gestational Age | Median | Inter-Quartile Range | weeks |
|
| STAT category | The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery) Congenital Heart Surgery Mortality Categories. The STAT Mortality Categories range from 1 to 5 with higher values indicating greater risk of mortality associated with operations for congenital heart disease | Number | participants |
|
| Cardiopulmonyar bypass time | Median | Inter-Quartile Range | minutes |
|
| Aortic cross clamp time | Median | Inter-Quartile Range | minutes |
|
| Intubated Pre-operatively | Subjects requiring mechanical ventilation in the pre-operative period for either respiratory or cardiac support. | Number | subjects |
|
|
|
|
| Primary | Post-operative Infection | Any positive culture or treatment for culture negative sepsis within 1 week of surgery | Posted | Number | Subjects | within 1 week of surgery |
|
|
|
|
| Primary | Blood Stream Infection | Any positive blood culture during the post-operative period until hospital discharge | Posted | Number | subjects | until Hospital Discharge, an average of 30 days |
|
|
|
|
| Primary | Blood Stream Infection Within 1 Week of Surgery | Posted | Number | subjects | 7 days |
|
|
|
|
| Secondary | Post-operative Plasma Albumin | Plasma albumin will be assessed at 24 and 48 hours. | Posted | Mean | Standard Deviation | g/dL | up to 48 hours post CPB |
|
|
|
|
| Secondary | Fluid Overload Variables | The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg. | Posted | Median | Inter-Quartile Range | mililiters/kilogram | 0-24 hours post-CPB |
|
|
|
|
| Secondary | Post-operative Inotrope Score | The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a "normal" scale or range used for this calculation. | Posted | Median | Inter-Quartile Range | inotropic score | first 48 hours post-CPB |
|
|
|
|
| Secondary | Respiratory Variables | Alive, ventilator free days will be recorded at hospital discharge. | Posted | Median | Inter-Quartile Range | days | until Hospital Discharge, an average of 30 days |
|
|
|
|
| Secondary | Hospital Discharge | From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days. | Posted | Median | Inter-Quartile Range | days | Approximately 1 month |
|
|
|
|
| Secondary | Plasma Immunoglobulins | Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op | Posted | Mean | Standard Deviation | mg/dL | 5 days post-op |
|
|
|
|
| Secondary | Interferon-gamma Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | Posted | Median | Inter-Quartile Range | pg/mL | Pre-operative to 48 hours post-operative |
|
|
|
|
| Secondary | Immunoglobulin Concentration in Chest Tube Drainage | Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative. | Posted | Median | Inter-Quartile Range | mg/dL | 24 hours post-op |
|
|
|
|
| Secondary | Mortality | Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge . | Posted | Number | subjects | Approximately 1 month |
|
|
|
|
| Secondary | Intensive Care Unit Length of Stay | The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0. | Posted | Median | Inter-Quartile Range | hours | 1 month |
|
|
|
|
| Secondary | Fluid Overload Variables | The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg. | Posted | Median | Inter-Quartile Range | militers/kilogram | 0-48 hours post-CPB |
|
|
|
|
| Secondary | Respiratory Variables | Time until first extubation in hours | Posted | Median | Inter-Quartile Range | hours | until extubation, an average of 2 days |
|
|
|
|
| Secondary | Respiratory Variables | Total time duration of post-operative length of mechanical ventilation until hospital discharge | Posted | Median | Inter-Quartile Range | hours | until extubation, an average of 2 days |
|
|
|
|
| Secondary | Interleukin-10 Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | Posted | Median | Inter-Quartile Range | pg/mL | pre-operative through 48 hours post-operative |
|
|
|
|
| Secondary | Interleukin-12p70 Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | Posted | Median | Inter-Quartile Range | pg/mL | pre-operative through 48 hours post-operative |
|
|
|
|
| Secondary | Interleukin-1b Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | Posted | Median | Inter-Quartile Range | pg/mL | pre-operative through 48 hours post-operative |
|
|
|
|
| Secondary | Interleukin-6 Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | Posted | Median | Inter-Quartile Range | pg/mL | pre-operative through 48 hours post-operative |
|
|
|
|
| Secondary | Interleukin-8 Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | Posted | Median | Inter-Quartile Range | pg/dL | pre-operative through 48 hours post-operative |
|
|
|
|
| Secondary | Tumor Necrosis Factor Plasma Cytokine Levels | Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively. | Posted | Median | Inter-Quartile Range | pg/dL | pre-operative through 48 hours post-operative |
|
|
|
|
| Secondary | Immunoglobulin Concentration in Peritoneal Dialysis Drainage | Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative. | Posted | Median | Inter-Quartile Range | mg/dL | 24 hours post-op |
|
|
|
|
| Secondary | Serum Creatinine | Pre-operative and 48 hour post-operative maximum creatinine recorded. | Posted | Mean | Standard Deviation | mg/dL | 48 hours |
|
|
|
|
| Secondary | Lactic Acid | Posted | Mean | Standard Deviation | mmol/L | pre-operative through 24 hours post-operative |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Normal Saline | Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. | 0 | 20 | 0 | 20 |
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| D008206 | Lymphatic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
48 hour post CPB albumin |
| t-test, 2 sided |
| 0.06 |
a p-value of <0.05 represents the threshold for test signficance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 24 hr post-op |
|
| 48 hr post-op |
|
12 hours post-operative inotrope score |
| Wilcoxon (Mann-Whitney) |
| 0.82 |
a p value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
power calculations were not performed on this statistical calculation |
| 24 hours post-operative inotrope score | Wilcoxon (Mann-Whitney) | 0.9 | a p value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | power calculations were not performed on this statistical calculation |
| 48 hours post-operative inotrope score | Wilcoxon (Mann-Whitney) | 0.23 | a p-value of <0.05 represents the threshold for statistical signficance | Non-Inferiority or Equivalence | power calculations were not performed on this statistical calculation |
| Post-operative day 3 serum IgG level |
|
| Post-operative day 5 serum IgG level |
|
12 hours post-operative IgG level |
| Wilcoxon (Mann-Whitney) |
| 0.36 |
a p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
power calculations were not performed on this statistical calculation |
| post-operative day 3 (72 hours) IgG level | Wilcoxon (Mann-Whitney) | <0.01 | p-value of <0.05 represents the threshold for statistical signficance | Non-Inferiority or Equivalence | power calculations were not performed on this statistical calculation |
| post-operative day 5 (120 hours) IgG level | Wilcoxon (Mann-Whitney) | <0.01 | p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | power calculations were not performed on this statistical calculation |
| 4 hour post-op |
|
| 12 hour post-op |
|
| 24 hour post-op |
|
| 48 hour post-op |
|
0 hour post-operative |
| Wilcoxon (Mann-Whitney) |
| 0.06 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 4 hour post-operative | Wilcoxon (Mann-Whitney) | 0.06 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hours post-operative | Wilcoxon (Mann-Whitney) | 0.33 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hours post-operative | Wilcoxon (Mann-Whitney) | 0.05 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 48 hours post-operative | Wilcoxon (Mann-Whitney) | 0.83 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 8 hr post-op |
|
| 12 hr post-op |
|
| 24 hr post-op |
|
4 hour level |
| Wilcoxon (Mann-Whitney) |
| 0.34 |
A p-value of <0.05 represents the threshold for statistical significance. |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 8 hour level | Wilcoxon (Mann-Whitney) | 0.14 | A p-value of <0.05 represents the threshold for statistical significance. | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hour level | Wilcoxon (Mann-Whitney) | 0.13 | A p-value of <0.05 represents the threshold for statistical significance. | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hour level | Wilcoxon (Mann-Whitney) | 0.02 | A p-value of <0.05 represents the threshold for statistical significance. | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 0-48 hours post-CPB |
|
0-24 hours post CPB |
| Wilcoxon (Mann-Whitney) |
| 0.52 |
A p-value of <0.05 represents the threshold for statistical significance. |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation. |
| 4 hour post-operative |
|
| 12 hour post-operative |
|
| 24 hour post-operative |
|
| 48 hour post-operatiave |
|
0 hour post-operative |
| Wilcoxon (Mann-Whitney) |
| 0.34 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 4 hour post-operative | Wilcoxon (Mann-Whitney) | 0.47 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hour post-operative | Wilcoxon (Mann-Whitney) | 0.42 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hour post-operative | Wilcoxon (Mann-Whitney) | 0.82 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 48 hour post-operative | Wilcoxon (Mann-Whitney) | 0.44 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 4 hour post-operative |
|
| 12 hour post-operative |
|
| 24 hour post-operative |
|
| 48 hour post-operatiave |
|
0 hour post-operative |
| Wilcoxon (Mann-Whitney) |
| 0.37 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 4 hour post-operative | Wilcoxon (Mann-Whitney) | 0.42 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hour post-operative | Wilcoxon (Mann-Whitney) | 0.31 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hour post-operative | Wilcoxon (Mann-Whitney) | 0.38 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 48 hour post-operative | Wilcoxon (Mann-Whitney) | 0.4 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 4 hour post-operative |
|
| 12 hour post-operative |
|
| 24 hour post-operative |
|
| 48 hour post-operatiave |
|
0 hour post-operative |
| Wilcoxon (Mann-Whitney) |
| 0.12 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 4 hour post-operative | Wilcoxon (Mann-Whitney) | 0.51 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hour post-operative | Wilcoxon (Mann-Whitney) | 0.27 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hour post-operative | Wilcoxon (Mann-Whitney) | 0.88 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 48 hour post-operative | Wilcoxon (Mann-Whitney) | 0.38 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 4 hour post-operative |
|
| 12 hour post-operative |
|
| 24 hour post-operative |
|
| 48 hour post-operatiave |
|
0 hour post-operative |
| Wilcoxon (Mann-Whitney) |
| 0.39 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 4 hour post-operative | Wilcoxon (Mann-Whitney) | 0.58 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hour post-operative | Wilcoxon (Mann-Whitney) | 0.36 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hour post-operative | Wilcoxon (Mann-Whitney) | 0.61 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 48 hour post-operative | Wilcoxon (Mann-Whitney) | 0.38 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 4 hour post-operative |
|
| 12 hour post-operative |
|
| 24 hour post-operative |
|
| 48 hour post-operatiave |
|
0 hour post-operative |
| Wilcoxon (Mann-Whitney) |
| 0.02 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 4 hour post-operative | Wilcoxon (Mann-Whitney) | 0.34 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hour post-operative | Wilcoxon (Mann-Whitney) | 0.35 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hour post-operative | Wilcoxon (Mann-Whitney) | 0.67 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 48 hour post-operative | Wilcoxon (Mann-Whitney) | 0.47 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 4 hour post-operative |
|
| 12 hour post-operative |
|
| 24 hour post-operative |
|
| 48 hour post-operatiave |
|
0 hour post-operative |
| Wilcoxon (Mann-Whitney) |
| 0.04 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 4 hour post-operative | Wilcoxon (Mann-Whitney) | 0.14 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hour post-operative | Wilcoxon (Mann-Whitney) | 0.82 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hour post-operative | Wilcoxon (Mann-Whitney) | 0.9 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 48 hour post-operative | Wilcoxon (Mann-Whitney) | 0.78 | A p-value of <0.05 represents the threshold for statistical significance | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 8 hr post-op |
|
| 12 hr post-op |
|
| 24 hr post-op |
|
4 hour level |
| Wilcoxon (Mann-Whitney) |
| 0.47 |
A p-value of <0.05 represents the threshold for statistical significance. |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
| 8 hour level | Wilcoxon (Mann-Whitney) | 0.47 | A p-value of <0.05 represents the threshold for statistical significance. | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 12 hour level | Wilcoxon (Mann-Whitney) | 0.79 | A p-value of <0.05 represents the threshold for statistical significance. | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
| 24 hour level | Wilcoxon (Mann-Whitney) | 0.04 | A p-value of <0.05 represents the threshold for statistical significance. | Non-Inferiority or Equivalence | Power calculations were not performed on this statistical calculation |
max |
| t-test, 2 sided |
| 0.68 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |
24 hour post-operative max |
| t-test, 2 sided |
| 0.79 |
A p-value of <0.05 represents the threshold for statistical significance |
| Non-Inferiority or Equivalence |
Power calculations were not performed on this statistical calculation |