Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery

• Sponsor: Northwell Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02046135
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arms: 2
• Duration (Months): 46.7
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury; Congenital Heart Disease	Drug: Sodium Bicarbonate; Drug: Sodium Chloride	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery: A Randomized Clinical Trial
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jul 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Sodium Bicarbonate
Active Comparator: 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.	Drug: Sodium Chloride

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Hospital and Intensive Care Unit Length of Stay [1 month]

   Hospital and intensive care unit length of stay in days

3. Need for Dialysis [1 month]

   Need for dialysis: yes/no

4. Length of Mechanical Ventilation [1 month]

   Length of mechanical ventilation in days

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cohen Children's Medical Center of New York	New Hyde Park	New York	United States	11040

Sponsors and Collaborators

• Northwell Health

Investigators

• Principal Investigator: James Schneider, MD, Cohen Children's Medical Center of New York

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 15, 2013

More Information

Publications

None provided.

• Responsible Party: James Schneider, Fellowship Director Critical Care, Northwell Health
• ClinicalTrials.gov Identifier: NCT02046135
• Other Study ID Numbers: 13-007B
• First Posted: Jan 27, 2014
• Last Update Posted: Dec 28, 2020
• Last Verified: Dec 1, 2020

• Keywords provided by James Schneider, Fellowship Director Critical Care, Northwell Health: Pediatric; Sodium bicarbonate; Acute kidney injury; Cardiac surgery
• Additional relevant MeSH terms: Acute Kidney Injury; Heart Diseases; Heart Defects, Congenital; Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	Sodium Bicarbonate	Sodium Chloride
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	26	25
COMPLETED	26	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sodium Bicarbonate	Sodium Chloride	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	26	25	51
Age (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	4.5	5	5
Sex: Female, Male (Count of Participants)
Female	13 50%	13 52%	26 51%
Male	13 50%	12 48%	25 49%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Height (centimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [centimeters]	60.5	62	61.6
Weight (kg) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg]	6	5.8	5.9

Outcome Measures

1. Primary Outcome

Title	Acute Kidney Injury
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sodium Bicarbonate	Sodium Chloride
Arm/Group Description	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	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
Measure Participants	26	25
Count of Participants [Participants]	19 73.1%	20 80%

2. Secondary Outcome

Title	Cumulative Fluid Balance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sodium Bicarbonate	Sodium Chloride
Arm/Group Description	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	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
Measure Participants	26	25
Median (Inter-Quartile Range) [mL]	-13.8	-12.4

3. Secondary Outcome

Title	Hospital and Intensive Care Unit Length of Stay
Description	Hospital and intensive care unit length of stay in days
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sodium Bicarbonate	Sodium Chloride
Arm/Group Description	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	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
Measure Participants	26	25
Median (Inter-Quartile Range) [days]	7.5	7.3

4. Secondary Outcome

Title	Need for Dialysis
Description	Need for dialysis: yes/no
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sodium Bicarbonate	Sodium Chloride
Arm/Group Description	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	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
Measure Participants	26	25
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Length of Mechanical Ventilation
Description	Length of mechanical ventilation in days
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sodium Bicarbonate	Sodium Chloride
Arm/Group Description	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	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
Measure Participants	26	25
Median (Inter-Quartile Range) [days]	3.8	1.2

Adverse Events

Time Frame	1 month
Arm/Group Title	Sodium Bicarbonate		Sodium Chloride
Arm/Group Description	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		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
All Cause Mortality
	Sodium Bicarbonate		Sodium Chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)
Serious Adverse Events
	Sodium Bicarbonate		Sodium Chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Sodium Bicarbonate		Sodium Chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)

Limitations/Caveats

Early termination leading to small number of subjects analyzed. This may lead to unreliable or uninterpretable data.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.