A multicentre, double-blind, randomised controlled trial of sodium bicarbonate to prevent acute kidney injury in patients undergoing cardiopulmonary bypass surgery. - Sodium Bicarbonate Study

• Conditions: Cardiac surgical patients in whom the use of cardiopulmonary bypass is planned and having at least one ore more of the following risk factors for post-operative acute kidney injury• Age = 70 years• Preoperative plasma creatinine >120 µmol/L• Heart failure (NYHA class III / IV)• Insulin dependent diabetes mellitus• Valve surgery (with or without coronary artery bypass graft surgery)• Redo cardiac surgery

• Registration Number: EUCTR2007-002223-32-IE
• Lead Sponsor: Charité Universitaetsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-26
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

Cardiac surgical patients in whom the use of cardiopulmonary bypass was planned and:
• Written informed consent of patient
• No present pregnancy
• Highly effective contraception in women with childbearing potential (Pearl index < 1)
• No participation in another clinical study (AMG) at the time of this study
and having at least one ore more of the following risk factors for post-operative acute kidney injury
• Age = 70 years
• Preoperative plasma creatinine >120 µmol/L
• Heart failure (NYHA class III / IV)
• Insulin dependent diabetes mellitus
• Valve surgery (with or without coronary artery bypass graft surgery)
• Redo cardiac surgery

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Cardiac surgical patients will not be considered eligible if:
• The use of cardiopulmonary bypass is not planned (off-pump cardiac surgery) or
• An emergency operation is indicated (within 24 hours after first description of cardiac symptoms)
• The above mentioned risk definition for post-operative acute kidney injury is not fulfilled or
• Women of childbearing age without highly effective contraception (PEARL-Index < 1%) or breastfeeding is present or
• Contraindications against the study medication are present such as alkalosis or hypokalemia or hypernatremia or
• Absent willingness to allow storage or circulation of coded data collected for study reason or
• Patient is accomodated in an institution of mental disorders on judicial or magisterial behalf or
• Patients participate in another clinical study (AMG) or
• Pre-operative end stage renal disease (serum creatinine >300 µmol/L) is present or
• Known blood-borne infectious disease is present or
• Chronic moderate to high dose corticosteroid therapy (>10 mg/d prednisone or equivalent) is present or
• Age is below 18 years,
• Legal responsibility
• Persons who are detained officially or legally to an official institute.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified