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Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery

Reduction of Acute Renal Failure Associated With Cardiovascular Surgery: A Randomized Study Comparing Sodium Bicarbonate to Normal Saline

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00484354
Enrollment
123
Registered
2007-06-08
Start date
2006-05-31
Completion date
2013-12-31
Last updated
2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Acute, Renal Replacement Therapy

Keywords

Acute Renal Failure, Cardiac Surgery, Sodium Bicarbonate, Length of Stay, Mortality

Brief summary

The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal saline. The volume of fluid given in each arm of the study is equal. All other interventions in those patients will be according to standard cardiothoracic anesthesia protocol at our institution.

Detailed description

This is a randomized, controlled, single center study in patients felt to be at high risk for ARF following CABG surgery. Patients who have met the selection criteria noted below will be randomized to one of two treatment arms: I) Patients allocated to the sodium bicarbonate (NaHCO3) arm will receive a 0.150 M NaHCO3 solution prepared in a sterile water base. An initial bolus of 0.150 M NaHCO3 at 5.0 ml/kg will be given over fifteen minutes prior to surgery. Following the bolus, the 0.150 M NaHCO3 infusion will be run at 1.0 ml/kg/hr during the procedure and for six (6) hours afterwards. The NaHCO3 infusion will then be decreased to 0.4 ml/kg/hr for a further twelve (12) hours. The goal in the NaHCO3 arm is to provide a total dose of approximately 2.5-3.0 mEq/kg of sodium bicarbonate. This dose was determined from prior studies and found to lead to a slight increase in the serum bicarbonate level post-operatively. Anecdotally, the metabolic stress of CABG surgery often leads to a decline in the serum bicarbonate level in patients not treated with alkali therapy. II) Patients allocated to the normal saline (NS) arm will receive an initial bolus consisting of 0.154 M NaCl (NS) at 5.0 ml/kg given over fifteen minutes prior to surgery. Following the bolus, these patients will receive NS (0.154 M) at a rate of 1.0 ml/kg/hour during the procedure and for six (6) hours afterwards. The rate will then be decreased to 0.4 ml/kg/hour for a further twelve (12) hours as done in the NaHCO3 treatment arm above. There will be a maximum rate of infusion of 125 mL/min used in both study arms to avoid volume overload issues in morbidly obese patients. There will be no other deviation from standard protocol when treating these patients undergoing CABG at our institution. The standard protocol is dictated by both the cardiothoracic surgeons and anesthesiologists involved with each individual case. The purpose of this study is to compare the incidence of ARF (maximal change in SCr) in high risk patients undergoing CABG when treated with either a NS or NaHCO3 maintenance infusion. This study will test the hypothesis that treatment with NaHCO3 may have a protective effect over NS in preventing AFR following CABG in a high risk population.

Interventions

DRUGSodium bicarbonate

IV bicarbonate given with amount based on patient weight

OTHERNormal saline

IV Normal saline with volume given determined by patient weight

IV bicarbonate, dosed by weight

OTHERPlacebo

Normal saline, with volume given based on patient weight

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Calculated GFR ≤ 60 ml/min/m2 (MDRD) OR * Any combination of two (2) of the following: * Age ≥ 70 * Complex surgery (any of the following): * CABG/Valve * Redo operation * Deep hypothermic arrest * ≥ 2 valves * History of PVD surgery * EF \< 35% * Presence of diabetes mellitus * Prior kidney transplant

Exclusion criteria

* Age \< 18 * Pre-existing ESRD (dialysis patients) * Pre-op GFR ≤ 15 ml/min/m2 * Pre-op bicarbonate level ≥ 30 mEq/L * Emergency surgery (unable to effectively consent) * Pregnancy * Heart transplant (OHT) * Aortic surgery (proximal or distal)

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Developed Acute Kidney Injury Within 72 Hours72 hours post-operativeNumber (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline

Secondary

MeasureTime frameDescription
Change in GFR Over 72 Hours Post Operatively72 hours25% or greater change in serum creatinine level
Length of Hospital StayUntil hospital discharge, up to 30 daysLength of hospital stay in days
Number of Participants With Need for DialysisUntil hospital discharge, up to 30 daysNumber of participants needing dialysis
MortalityUntil hospital discharge, up to 30 daysNumber of patients who died during the hospitalization

Countries

United States

Participant flow

Participants by arm

ArmCount
IV Sodium Bicarbonate
IV sodium bicarbonate given with amount based on patient weight
64
IV Normal Saline
IV Normal saline with volume given determined by patient weight
59
Total123

Baseline characteristics

CharacteristicIV Normal SalineTotalIV Sodium Bicarbonate
Age, Continuous69.7 years
STANDARD_DEVIATION 13.5
70 years
STANDARD_DEVIATION 13
70.2 years
STANDARD_DEVIATION 12.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
9 Participants14 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants5 Participants2 Participants
Race (NIH/OMB)
White
47 Participants104 Participants57 Participants
Region of Enrollment
United States
59 participants123 participants64 participants
Sex: Female, Male
Female
16 Participants46 Participants30 Participants
Sex: Female, Male
Male
43 Participants77 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
9 / 6310 / 57
other
Total, other adverse events
4 / 635 / 57
serious
Total, serious adverse events
9 / 6310 / 57

Outcome results

Primary

Number of Participants Who Developed Acute Kidney Injury Within 72 Hours

Number (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline

Time frame: 72 hours post-operative

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IV Sodium BicarbonateNumber of Participants Who Developed Acute Kidney Injury Within 72 Hours17 Participants
IV Normal SalineNumber of Participants Who Developed Acute Kidney Injury Within 72 Hours14 Participants
Secondary

Change in GFR Over 72 Hours Post Operatively

25% or greater change in serum creatinine level

Time frame: 72 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IV Sodium BicarbonateChange in GFR Over 72 Hours Post Operatively21 Participants
IV Normal SalineChange in GFR Over 72 Hours Post Operatively21 Participants
Secondary

Length of Hospital Stay

Length of hospital stay in days

Time frame: Until hospital discharge, up to 30 days

ArmMeasureValue (MEAN)Dispersion
IV Sodium BicarbonateLength of Hospital Stay14.2 daysStandard Deviation 15.4
IV Normal SalineLength of Hospital Stay14.6 daysStandard Deviation 14.4
Secondary

Mortality

Number of patients who died during the hospitalization

Time frame: Until hospital discharge, up to 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IV Sodium BicarbonateMortality9 Participants
IV Normal SalineMortality10 Participants
Secondary

Number of Participants With Need for Dialysis

Number of participants needing dialysis

Time frame: Until hospital discharge, up to 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IV Sodium BicarbonateNumber of Participants With Need for Dialysis4 Participants
IV Normal SalineNumber of Participants With Need for Dialysis5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026