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Acute kidney injury (AKI) after cardiopulmonary bypass (CPB) in infants is common and associated with poor outcomes. Peritoneal dialysis (PD) and furosemide have been used to attain negative fluid balance due to AKI induced oliguria, but have not been compared prospectively. The investigators will prospectively compare outcomes of infants with oliguria after CPB randomized to PD vs. furosemide with the hypothesis that infants receiving PD have superior outcomes.
Background: Acute kidney injury (AKI) is a common postoperative complication after heart surgery with cardiopulmonary bypass (CPB). Multiple studies have demonstrated that patients with AKI have worse clinical outcomes, such as longer ventilation times and increased length of stay, which is thought to be secondary to associated oliguria and subsequent fluid overload. Studies suggest that early renal replacement therapy (RRT) via peritoneal dialysis (PD) may prevent fluid overload and therefore be a superior management to diuretic (i.e. furosemide) administration. However, there is no published evidence to suggest superiority or laboratory data available to guide decision making.
Objective: Our primary objective is to determine if early institution of PD improves clinical outcomes compared to administration of furosemide in post-operative cardiac infants with acute kidney injury. We hypothesize that early initiation of PD will improve clinical outcomes. We will determine if these clinical outcomes will be better among good responders of furosemide compared to poor responders. We will determine if postoperative NGAL concentrations are predictive of poor response to furosemide.
Design / Methods: The study will be a single-center randomized clinical trial among neonates undergoing cardiac surgery with CPB with planned placement of a PD catheter due to risk of AKI. If patients demonstrate oliguria within the first postoperative day, they will be randomized to early PD or trial of furosemide. Clinical and laboratory data will be collected and compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide | Experimental | Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service. |
|
| Peritoneal dialysis | Experimental | Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management will be directed by CICU attending and Nephrology service |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Negative Fluid Balance on Postop Day 1 | Difference of inputs and outputs, including urine output and PD drainage. | Postop day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Support Administered | Duration of initial course of postoperative mechanical ventilation | Duration of postoperative intubation (average time approximately- 1 week) |
| NGAL Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Kwiatkowski, MD | Cinncinnati Children's Hospital Medical Center | Principal Investigator |
| Catherine D Krawczeski, MD | Cinncinnati Children's Hospital Medical Center | Study Director |
| Stuart L Goldstein, MD | Cinncinnati Children's Hospital Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45223 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28241247 | Derived | Kwiatkowski DM, Goldstein SL, Cooper DS, Nelson DP, Morales DL, Krawczeski CD. Peritoneal Dialysis vs Furosemide for Prevention of Fluid Overload in Infants After Cardiac Surgery: A Randomized Clinical Trial. JAMA Pediatr. 2017 Apr 1;171(4):357-364. doi: 10.1001/jamapediatrics.2016.4538. |
| Label | URL |
|---|---|
| Center for Acute Care Nephology at Cincinnati Childrens | View source |
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De-identified patient data would be available to other researchers after publication of data at the discretion of the research team after communication with the PI
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| ID | Title | Description |
|---|---|---|
| FG000 | Furosemide | Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service. Furosemide: Patients randomized to the furosemide arm are given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix |
| FG001 | Peritoneal Dialysis | Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management will be directed by CICU attending and Nephrology service Peritoneal Dialysis: Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service. One potential outcome during use of a peritoneal dialysis catheter is the development of a Pleural Peritoneal communication. In this event, dialysis fluid is instilled in the peritoneum and then leaks into the pleural space through a defect in the diaphragm. This fluid is then drained out of a surgical chest tube. This impairs the ability to perform peritoneal dialysis and thus is a reason to not complete the randomized arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Furosemide | Patients randomized to receive furosemide |
| BG001 | Peritoneal Dialysis | Patients randomized to receive peritoneal dialysis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Negative Fluid Balance on Postop Day 1 | Difference of inputs and outputs, including urine output and PD drainage. | Posted | Count of Participants | Participants | Postop day 1 |
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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 | Furosemide | Patients randomized to furosemide | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Event | Blood and lymphatic system disorders | Systematic Assessment | Bleeding from PD catheter or relating to its placement requiring blood product transfusion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Kwiatkowski | Stanford University | 650-721-3290 | david.kwiatkowski@stanford.edu |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D010530 | Peritoneal Dialysis |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
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| Peritoneal Dialysis | Procedure | Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service. |
|
|
| Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr) |
| Duration of Cardiac ICU Stay | Total days of initial postoperative stay in cardiac ICU | Average 2 weeks |
| Duration of Hospital Stay | Total days of initial postoperative stay in hospital | Average 4 weeks |
| All Cause Mortality | In-hospital mortality | duration of hospitalization (an average of 2 weeks) |
| Renal/Electrolyte Abnormalities | Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol | Postop morning 1-5 |
| Doses of Potassium Chloride or Arginine Chloride Required | Total doses of potassium chloride or arginine chloride given during the first five postoperative days. | Postop day 0-5 |
| B-Natriuretic Peptide | BNP measured at 24 and 48 hours postoperatively | At 24hours and 48 hours postoperative |
| Modified Oxygenation Index | Product of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen | at 24 and 48 hours postoperative |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Median | Inter-Quartile Range | kg |
|
| Length (cm) | Median | Inter-Quartile Range | cm |
|
| Baseline Creatinine (mg/dL) | Median | Inter-Quartile Range | mg/dl |
|
|
|
| Secondary | Respiratory Support Administered | Duration of initial course of postoperative mechanical ventilation | Posted | Median | Inter-Quartile Range | days | Duration of postoperative intubation (average time approximately- 1 week) |
|
|
|
| Secondary | NGAL Concentration | Data were collected but not analyzed. Due to a high incidence of volatile and un-reportable NGAL levels, concerns were raised about the storage or processing of samples affecting data validity. Given the overwhelming concern of erroneous data, analysis was not performed as planned. | Posted | Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr) |
|
|
| Secondary | Duration of Cardiac ICU Stay | Total days of initial postoperative stay in cardiac ICU | Posted | Median | Inter-Quartile Range | days | Average 2 weeks |
|
|
|
| Secondary | Duration of Hospital Stay | Total days of initial postoperative stay in hospital | Posted | Median | Inter-Quartile Range | days | Average 4 weeks |
|
|
|
| Secondary | All Cause Mortality | In-hospital mortality | Posted | Count of Participants | Participants | duration of hospitalization (an average of 2 weeks) |
|
|
|
| Secondary | Renal/Electrolyte Abnormalities | Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol | Posted | Median | Inter-Quartile Range | abnormalities | Postop morning 1-5 |
|
|
|
| Secondary | Doses of Potassium Chloride or Arginine Chloride Required | Total doses of potassium chloride or arginine chloride given during the first five postoperative days. | Posted | Median | Inter-Quartile Range | doses given | Postop day 0-5 |
|
|
|
| Secondary | B-Natriuretic Peptide | BNP measured at 24 and 48 hours postoperatively | Posted | Mean | Inter-Quartile Range | pg/ml | At 24hours and 48 hours postoperative |
|
|
|
| Secondary | Modified Oxygenation Index | Product of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen | Posted | Median | Inter-Quartile Range | Units | at 24 and 48 hours postoperative |
|
|
|
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Peritoneal Dialysis | Patients randomized to peritoneal dialysis | 1 | 41 | 0 | 41 | 2 | 41 |
|
| Hydrocele | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Development of hydrocele |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D006435 | Renal Dialysis |
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |