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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00484354
First Posted: June 8, 2007
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
June 6, 2007
June 8, 2007
November 6, 2017
May 2006
December 2011   (Final data collection date for primary outcome measure)
Maximum change in serum creatinine level (SCr) over the 72 hour post-operative period [ Time Frame: 72 hours post-operative ]
Same as current
Complete list of historical versions of study NCT00484354 on ClinicalTrials.gov Archive Site
  • Maximum change in GFR over 72 hours post operatively [ Time Frame: 2 weeks ]
  • Length of hospital stay [ Time Frame: 2 weeks ]
  • Incidence of need for dialysis for treatment of acute renal failure [ Time Frame: 2 weeks ]
  • Mortality [ Time Frame: 2 weeks ]
a) Maximum change in GFR over 72 hrs post operatively b) Length of hospital stay c) Incidence of need for dialysis for treatment of acute renal failure d) Mortality [ Time Frame: 2 weeks ]
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Kidney Failure, Acute
  • Renal Replacement Therapy
  • Other: Sodium bicarbonate
    IV bicarbonate given with amount based on patient weight
  • Other: Normal saline
    IV Normal saline with volume given determined by patient weight
  • Other: Bicarbonate
    IV bicarbonate, dosed by weight
  • Other: Placebo
    Normal saline, with volume given based on patient weight
  • Active Comparator: 1
    Bicarbonate administration
    Interventions:
    • Other: Sodium bicarbonate
    • Other: Bicarbonate
  • Placebo Comparator: 2
    Normal saline administration
    Interventions:
    • Other: Normal saline
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
December 2013
December 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00484354
IRB00002409
Yes
Not Provided
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
Not Provided
Principal Investigator: Michael V. Rocco, MD Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology
Wake Forest University Health Sciences
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP