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| Name | Class |
|---|---|
| Women and Children's Health Research Institute, Canada | OTHER |
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Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart surgeries before they turn three years of age. The first surgery typically happens in the first two weeks of life. After this operation, babies come back to the intensive care unit with their chests open. Babies who have heart surgery retain body water after surgery and this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of the extra water. As a result, babies have to stay in the intensive care unit and on a breathing machine for longer.
Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD involves putting small amounts of special fluid into the belly through the catheter. This special fluid attracts water and is drained hourly. By allowing the belly cavity to drain, this helps both the heart and the lungs. This allows the chest to be closed and the breathing tube to be removed. The investigators are looking to see how quickly the babies, with and without PD, get rid of the extra water in turn shortening their stay in the intensive care unit and in the hospital. PD is not permanent, and only used for the first few days after the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic peritoneal dialysis | Experimental | Prophylactic peritoneal dialysis |
|
| Standard care without PDC | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peritoneal dialysis | Device | Prophylactic peritoneal dialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Post-operative Negative 24 Hour Fluid Balance | Time to first post-operative negative fluid balance which occurred in first 72 hrs | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Sternal Closure | Up to 200 hours | |
| Time to Lactate Less Than or Equal to 2mmol/L | Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs | From time of admission in PICU until assessment was reached, assessed up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay M Ryerson, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25218539 | Derived | Ryerson LM, Mackie AS, Atallah J, Joffe AR, Rebeyka IM, Ross DB, Adatia I. Prophylactic peritoneal dialysis catheter does not decrease time to achieve a negative fluid balance after the Norwood procedure: a randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):222-8. doi: 10.1016/j.jtcvs.2014.08.011. Epub 2014 Aug 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prophylactic Peritoneal Dialysis | A peritoneal dialysis catheter (PDC) was inserted at the time of the Norwood operation. The PDC was left open to drainage until the patient was stable enough to start peritoneal dialysis cycles. Criteria to start PD cycles included: no fluid bolus given within the past four hours; no escalation of inotropes or vasopressors within the last two hours; vasoactive inotropes score (VIS) ≤ 15; and oxygen saturations ≥ 65% on FiO2 ≤ 0.4. PD cycles consisted initially of 10 ml/kg dwell volumes with initial 1.5% dextrose concentration and 60 minute manual cycles (in/dwell 40 minutes, drain 20 minutes). |
| FG001 | Standard Care Without PDC | This group did not receive a peritoneal dialysis catheter at the time of their Norwood. This group received standard care according to their attending physician. At our institution, diuresis is typically initiated with furosemide, either by continuous infusion or bolus dosing at the discretion of the treating team. Study design allowed for placement of a peritoneal dialysis catheter if clinically indicated due to recalcitrant hyperkalemia (serum potassium > 5.9 mEq/L), volume overload unresponsive to diuretics, abdominal compartment syndrome, oliguria (urine output < 1 ml/kg/hr) for more than four hours despite medical intervention or increased serum creatinine in association with persistent metabolic acidosis or low cardiac output syndrome (LCOS). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prophylactic Peritoneal Dialysis | Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis |
| BG001 | Standard Care Without PDC | Standard care with diuretics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to First Post-operative Negative 24 Hour Fluid Balance | Time to first post-operative negative fluid balance which occurred in first 72 hrs | Posted | Mean | Standard Deviation | Days | up to 72 hours |
|
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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 | Prophylactic Peritoneal Dialysis | Prophylactic peritoneal dialysis Peritoneal dialysis: Prophylactic peritoneal dialysis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CPR | Cardiac disorders | Systematic Assessment | Cardiopulmonary resuscitation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter leakage | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lindsay Ryerson | University of Alberta | 780 407 3396 | 780 | ryerson@ualberta.ca |
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| ID | Term |
|---|---|
| D018636 | Hypoplastic Left Heart Syndrome |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D010530 | Peritoneal Dialysis |
| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
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| Time to First Extubation | Up to 15 days |
| Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5 | The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes. | Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported |
| Hospital Length of Stay | Assessed up to 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Time to Sternal Closure | Posted | Mean | Standard Deviation | days | Up to 200 hours |
|
|
|
| Secondary | Time to Lactate Less Than or Equal to 2mmol/L | Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs | Posted | Mean | Standard Deviation | Hours | From time of admission in PICU until assessment was reached, assessed up to 24 hours |
|
|
|
| Secondary | Time to First Extubation | Posted | Mean | Standard Deviation | days | Up to 15 days |
|
|
|
| Secondary | Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5 | The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported |
|
|
|
| Secondary | Hospital Length of Stay | Posted | Mean | Standard Deviation | days | Assessed up to 8 weeks |
|
|
|
| 1 |
| 10 |
| 4 |
| 10 |
| 6 |
| 10 |
| EG001 | Standard Care Without PDC | 0 | 12 | 0 | 12 | 0 | 12 |
| ECLS | Cardiac disorders | Systematic Assessment | Extracorporeal life support |
|
| Retention of PD fluid | Renal and urinary disorders | Systematic Assessment |
|
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |