Trial Outcomes & Findings for Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery (NCT NCT02046135)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

7 days

Results posted on

2022-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	26	25
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sodium Bicarbonate n=26 Participants 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	Sodium Chloride n=25 Participants 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 n=51 Participants Total of all reporting groups
Age, Continuous	4.5 months n=26 Participants	5 months n=25 Participants	5 months n=51 Participants
Sex: Female, Male Female	13 Participants n=26 Participants	13 Participants n=25 Participants	26 Participants n=51 Participants
Sex: Female, Male Male	13 Participants n=26 Participants	12 Participants n=25 Participants	25 Participants n=51 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	60.5 centimeters n=26 Participants	62 centimeters n=25 Participants	61.6 centimeters n=51 Participants
Weight	6 kg n=26 Participants	5.8 kg n=25 Participants	5.9 kg n=51 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=26 Participants 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	Sodium Chloride n=25 Participants 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
Acute Kidney Injury	19 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=26 Participants 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	Sodium Chloride n=25 Participants 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
Cumulative Fluid Balance	-13.8 mL Interval -219.4 to 130.8	-12.4 mL Interval -277.8 to 69.0

SECONDARY outcome

Timeframe: 1 month

Hospital and intensive care unit length of stay in days

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=26 Participants 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	Sodium Chloride n=25 Participants 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
Hospital and Intensive Care Unit Length of Stay	7.5 days Interval 4.4 to 16.1	7.3 days Interval 4.4 to 14.1

SECONDARY outcome

Timeframe: 1 month

Need for dialysis: yes/no

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=26 Participants 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	Sodium Chloride n=25 Participants 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
Need for Dialysis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

Length of mechanical ventilation in days

Outcome measures

Outcome measures
Measure	Sodium Bicarbonate n=26 Participants 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	Sodium Chloride n=25 Participants 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
Length of Mechanical Ventilation	3.8 days Interval 1.2 to 6.8	1.2 days Interval 1.1 to 2.1

Adverse Events

Sodium Bicarbonate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sodium Chloride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. James Schneider

Cohen Children's Medical Center

Phone: 7184703330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place