Prevention of Acute Kidney Injury in Cardiac Surgery Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Judith L. Kristeller, Community Medical Center, Scranton, PA
ClinicalTrials.gov Identifier:
NCT00921518
First received: June 15, 2009
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients following cardiac surgery, and at least 50% of patients with underlying renal insufficiency. Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of developing post-operative AKI. The purpose of the current study is to determine if intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is effective at preventing post-operative AKI in patients with baseline kidney insufficiency and who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.


Condition Intervention Phase
Kidney Injury
Drug: 0.9% Sodium Chloride (Placebo)
Drug: Sodium Bicarbonate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Acute Kidney Injury in Cardiac Surgery Patients

Resource links provided by NLM:


Further study details as provided by Community Medical Center, Scranton, PA:

Primary Outcome Measures:
  • Number of Participants With Acute Kidney Injury [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Acuge kidney injury is defined using the AKIN criteria


Enrollment: 92
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline
This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Drug: 0.9% Sodium Chloride (Placebo)
0.9% Sodium Chloride (placebo) will infuse at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Other Name: Normal Saline
Active Comparator: Sodium Bicarbonate
This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Drug: Sodium Bicarbonate
Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Other Name: Bicarbonate

Detailed Description:

This is a randomized, placebo-controlled, prospective, double-blinded. The study will take place at Community Medical Center in Scranton, Pennsylvania. The inclusion criteria are patients undergoing elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass and having a baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation. Patients will be excluded from the study if they have cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump), end-stage kidney disease requiring dialysis, received an infusion of sodium bicarbonate on the same day as cardiac surgery, or if they are enrolled in a separate clinical research trial. This trial will involve two treatment groups. Group one will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution using the same infusion regimen as described above for isotonic saline. The primary efficacy outcome of the study will be the incidence of AKI postoperatively. Acute kidney injury will be defined as an increase in serum creatinine concentration by at least 25% from baseline or an absolute increase of 0.5 mg/dL at any time within the first five postoperative days.

  Eligibility

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

Inclusion Criteria:

  • elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass
  • baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation

Exclusion Criteria:

  • cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump)
  • end-stage kidney disease requiring dialysis
  • received an infusion of sodium bicarbonate on the same day as cardiac surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921518

Locations
United States, Pennsylvania
Community Medical Center
Scranton, Pennsylvania, United States, 18510
Sponsors and Collaborators
Community Medical Center, Scranton, PA
Investigators
Principal Investigator: Judith L Kristeller, PharmD Wilkes University
  More Information

Publications:
Responsible Party: Judith L. Kristeller, Associate Professor, Community Medical Center, Scranton, PA
ClinicalTrials.gov Identifier: NCT00921518     History of Changes
Other Study ID Numbers: CMC AKICS
Study First Received: June 15, 2009
Results First Received: January 28, 2014
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Community Medical Center, Scranton, PA:
Cardiac surgery
Sodium bicarbonate
Acute kidney injury
Saline

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

ClinicalTrials.gov processed this record on April 17, 2014