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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Rocco, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00484354
First received: June 6, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention
Kidney Failure, Acute
Renal Replacement Therapy
Other: Sodium bicarbonate
Other: Normal saline
Other: Bicarbonate
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Maximum change in serum creatinine level (SCr) over the 72 hour post-operative period [ Time Frame: 72 hours post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum change in GFR over 72 hours post operatively [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Incidence of need for dialysis for treatment of acute renal failure [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: May 2006
Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bicarbonate administration
Other: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484354

Locations
United States, North Carolina
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Michael V. Rocco, MD Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology
  More Information

No publications provided

Responsible Party: Michael Rocco, Principal Investigator, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00484354     History of Changes
Other Study ID Numbers: IRB00002409
Study First Received: June 6, 2007
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Acute Renal Failure
Cardiac Surgery
Sodium Bicarbonate
Length of Stay
Mortality

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014