Prevention of Acute Kidney Injury in Cardiac Surgery Patients

• ClinicalTrials.gov Identifier: NCT00921518
• Recruitment Status: Completed
• First Posted: June 16, 2009
• Results First Posted: March 11, 2014
• Last Update Posted: April 15, 2014
• Sponsor: Community Medical Center, Scranton, PA
• Information provided by (Responsible Party): Judith L. Kristeller, Community Medical Center, Scranton, PA

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Kidney Injury	Drug: 0.9% Sodium Chloride (Placebo); Drug: Sodium Bicarbonate	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Prevention of Acute Kidney Injury in Cardiac Surgery Patients
• Study Start Date: January 2009
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Acute Kidney Injury [ Time Frame: 5 days ]
   Acuge kidney injury is defined using the AKIN criteria

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 of Results:

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.

• Responsible Party: Judith L. Kristeller, Associate Professor, Community Medical Center, Scranton, PA
• ClinicalTrials.gov Identifier: NCT00921518
• Other Study ID Numbers: CMC AKICS
• First Posted: June 16, 2009
• Results First Posted: March 11, 2014
• Last Update Posted: April 15, 2014
• Last Verified: March 2014

Keywords provided by Judith L. Kristeller, 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