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

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ClinicalTrials.gov Identifier: NCT00484354

Recruitment Status : Completed

First Posted : June 8, 2007

Results First Posted : October 16, 2018

Last Update Posted : October 16, 2018

Sponsor:

Information provided by (Responsible Party):

Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Kidney Failure, Acute Renal Replacement Therapy	Drug: Sodium bicarbonate Other: Normal saline Other: Bicarbonate Other: Placebo	Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	123 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Reduction of Acute Renal Failure Associated With Cardiovascular Surgery: A Randomized Study Comparing Sodium Bicarbonate to Normal Saline
Study Start Date :	May 2006
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 Bicarbonate administration	Drug: Sodium bicarbonate IV bicarbonate given with amount based on patient weight Other: Bicarbonate IV bicarbonate, dosed by weight
Placebo Comparator: 2 Normal saline administration	Other: Normal saline IV Normal saline with volume given determined by patient weight Other: Placebo Normal saline, with volume given based on patient weight

Outcome Measures

Primary Outcome Measures :

Number of Participants Who Developed Acute Kidney Injury Within 72 Hours [ Time Frame: 72 hours post-operative ]
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

Secondary Outcome Measures :

Change in GFR Over 72 Hours Post Operatively [ Time Frame: 72 hours ]
25% or greater change in serum creatinine level
Length of Hospital Stay [ Time Frame: Until hospital discharge, up to 30 days ]
Length of hospital stay in days
Number of Participants With Need for Dialysis [ Time Frame: Until hospital discharge, up to 30 days ]
Number of participants needing dialysis
Mortality [ Time Frame: Until hospital discharge, up to 30 days ]
Number of patients who died during the hospitalization

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Calculated GFR ≤ 60 ml/min/m2 (MDRD)

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484354

Locations


United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators


Principal Investigator:	Michael V. Rocco, MD	Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology

More Information


Responsible Party:	Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT00484354 History of Changes
Other Study ID Numbers:	IRB00002409
First Posted:	June 8, 2007 Key Record Dates
Results First Posted:	October 16, 2018
Last Update Posted:	October 16, 2018
Last Verified:	September 2018


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Wake Forest University Health Sciences:


Acute Renal Failure Cardiac Surgery Sodium Bicarbonate Length of Stay Mortality

Additional relevant MeSH terms:


Renal Insufficiency Acute Kidney Injury Kidney Diseases Urologic Diseases

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