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Clinical Trials/EUCTR2007-002223-32-IE
EUCTR2007-002223-32-IE
Active, not recruiting
Not Applicable

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

Charité Universitaetsmedizin0 sites402 target enrollmentMarch 26, 2009
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ConditionsCardiac 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
DrugsSodium bicarbonateSodium chloride

Overview

Phase
Not Applicable
Intervention
Not specified
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
Sponsor
Charité Universitaetsmedizin
Enrollment
402
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 26, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Charité Universitaetsmedizin

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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