Prevention of Acute Kidney Injury in Cardiac Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Kidney Injury
• Intervention / Treatment: Drug: 0.9% Sodium Chloride (Placebo); Drug: Sodium 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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Scranton, Pennsylvania, United States, 18510
      • Community Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Acute Kidney Injury	Acuge kidney injury is defined using the AKIN criteria	5 days

Collaborators and Investigators

• Sponsor: Community Medical Center, Scranton, PA
• Investigators: Principal Investigator: Judith L Kristeller, PharmD, Wilkes University

Publications and helpful links

General Publications

• Kristeller JL, Zavorsky GS, Prior JE, Keating DA, Brady MA, Romaldini TA, Hickman TL, Stahl RF. Lack of effectiveness of sodium bicarbonate in preventing kidney injury in patients undergoing cardiac surgery: a randomized controlled trial. Pharmacotherapy. 2013 Jul;33(7):710-7. doi: 10.1002/phar.1262. Epub 2013 Apr 1.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 15, 2009
• First Submitted That Met QC Criteria: June 15, 2009
• First Posted (Estimate): June 16, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Saline; Acute kidney injury; Cardiac surgery; Sodium bicarbonate
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: CMC AKICS