Prevention of Acute Kidney Injury in Cardiac Surgery Patients

NCT00921518 | Completed Phase 2 Results DMC

• 1 other identifier: CMC AKICS
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Injury

Keywords

Cardiac surgery; Sodium bicarbonate; Acute kidney injury; Saline

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Kidney Injury

  Acuge kidney injury is defined using the AKIN criteria

  5 days

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

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)

Sodium Bicarbonate

ACTIVE COMPARATOR

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

Interventions

0.9% Sodium Chloride (Placebo) DRUG

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.

Also known as: Normal Saline

Normal Saline

Sodium Bicarbonate DRUG

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.

Also known as: Bicarbonate

Sodium Bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Community Medical Center, Scranton, PA: lead

Study Sites (1)

Community Medical Center

Scranton, Pennsylvania, 18510, United States

Location

Related Publications (1)

• 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.

  PMID: 23553549 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Chloride; Saline Solution; Sodium Bicarbonate; Bicarbonates

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Anions; Ions; Electrolytes

Results Point of Contact

• Title: Judith Kristeller
• Organization: Wilkes University

judith.kristeller@wilkes.edu

570-408-4272

Study Officials

• Judith L Kristeller, PharmD

  Wilkes University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 15, 2014
• Results First Posted: March 11, 2014

Record last verified: 2014-03

Locations

US (1)