Acute Kidney Injury, Congenital Heart Disease
Conditions
Keywords
Pediatric, Sodium bicarbonate, Acute kidney injury, Cardiac surgery
Brief summary
The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows: 1\. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.
Interventions
DRUGSodium Bicarbonate
DRUGSodium Chloride
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects age ≤18 years 2. Subjects scheduled for cardiac surgery with cardiopulmonary bypass
Exclusion criteria
1. Subjects with abnormal creatinine clearance (\<90 ml/min/1.7m2) as measured by the Schwartz formula 2. Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved) 3. Subjects with known metabolic disorder 4. Premature infants born \<30 weeks gestation and \<30 days old due to risk of intraventricular hemorrhage Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Kidney Injury | 7 days | The number of patients who developed AKI in each arm of the study. AKI was measured by the Pediatric Risk, Failure, Loss of Function, and End-Stage Renal Disease (pRIFLE) criteria or an absolute increase in creatinine of 0.3mg/dl. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Fluid Balance | 6 days | Cumulative fluid balance in milliliters- comparison of all fluid intake vs all fluid output from the time of ICU admission post-operatively for the first 6 days post-operatively or until the time of discharge, whichever came first. |
| Hospital and Intensive Care Unit Length of Stay | 1 month | Hospital and intensive care unit length of stay in days |
| Need for Dialysis | 1 month | Need for dialysis: yes/no |
| Length of Mechanical Ventilation | 1 month | Length of mechanical ventilation in days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sodium Bicarbonate At the start of the surgery, the patient will receive NaHCO3 as a continuous infusion of D5% 1/3NS + 100 meq/L NaHCO3 + 20 meq/L KCl at maintenance IVF (solution contains \
154 meq of sodium which is equivalent to normal saline). The NaHCO3 infusion will continue for the first 24 hours after the discontinuation of CPB. After 24 hours of receiving the NaHCO3 infusion, the IVF administered to the patient will be the standard solutions used in the PICU at CCMC.
Sodium Bicarbonate | 26 |
| Sodium Chloride At the start of surgery, patients in the control arm will receive D5% Normal Saline + 20 meq/L KCl at maintenance IVF. After 24 hours, standard IVF, not containing NaHCO3 or Na acetate will be administered for the duration of the PICU stay as required, determined by the clinicians primarily caring for the patient postoperatively.
Sodium Chloride | 25 |
| Total | 51 |
Baseline characteristics
| Characteristic | Sodium Chloride | Sodium Bicarbonate | Total |
|---|---|---|---|
| Age, Continuous | 5 months | 4.5 months | 5 months |
| Height | 62 centimeters | 60.5 centimeters | 61.6 centimeters |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
| Weight | 5.8 kg | 6 kg | 5.9 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 0 / 26 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
Primary
Acute Kidney Injury
The number of patients who developed AKI in each arm of the study. AKI was measured by the Pediatric Risk, Failure, Loss of Function, and End-Stage Renal Disease (pRIFLE) criteria or an absolute increase in creatinine of 0.3mg/dl.
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sodium Bicarbonate | Acute Kidney Injury | 19 Participants |
| Sodium Chloride | Acute Kidney Injury | 20 Participants |
Secondary
Cumulative Fluid Balance
Cumulative fluid balance in milliliters- comparison of all fluid intake vs all fluid output from the time of ICU admission post-operatively for the first 6 days post-operatively or until the time of discharge, whichever came first.
Time frame: 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sodium Bicarbonate | Cumulative Fluid Balance | -13.8 mL |
| Sodium Chloride | Cumulative Fluid Balance | -12.4 mL |
Secondary
Hospital and Intensive Care Unit Length of Stay
Hospital and intensive care unit length of stay in days
Time frame: 1 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sodium Bicarbonate | Hospital and Intensive Care Unit Length of Stay | 7.5 days |
| Sodium Chloride | Hospital and Intensive Care Unit Length of Stay | 7.3 days |
Secondary
Length of Mechanical Ventilation
Length of mechanical ventilation in days
Time frame: 1 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sodium Bicarbonate | Length of Mechanical Ventilation | 3.8 days |
| Sodium Chloride | Length of Mechanical Ventilation | 1.2 days |
Secondary
Need for Dialysis
Need for dialysis: yes/no
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sodium Bicarbonate | Need for Dialysis | 0 Participants |
| Sodium Chloride | Need for Dialysis | 0 Participants |