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Completed

NCT Number: NCT00484354

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sodium bicarbonate

Drug

IV bicarbonate given with amount based on patient weight

Normal Saline

Other

IV Normal saline with volume given determined by patient weight

Bicarbonate

Other

IV bicarbonate, dosed by weight

Placebo

Other

Normal saline, with volume given based on patient weight

Primary outcomes

  1. 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 outcomes

  1. Change in GFR Over 72 Hours Post Operatively

    Time frame: 72 hours

    25% or greater change in serum creatinine level

  2. Length of Hospital Stay

    Time frame: Until hospital discharge, up to 30 days

    Length of hospital stay in days

  3. Number of Participants With Need for Dialysis

    Time frame: Until hospital discharge, up to 30 days

    Number of participants needing dialysis

  4. Mortality

    Time frame: Until hospital discharge, up to 30 days

    Number of patients who died during the hospitalization

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2013
First posted
Jun 8, 2007
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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