Status:
UNKNOWN
Preop Hemodialysis or Intraop Ultrafiltration for Patients With Severe Renal Dysfunction Undergoing Open Heart Surgery
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
University of Gaziantep
Ankara University
Conditions:
Non-Dialysis Dependent Severe Renal Dysfunction
Cardiovascular Disease
Eligibility:
All Genders
18-95 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether preoperative hemodialysis or intraoperative modified ultrafiltration are effective for patients with non-dialysis dependent severe renal dysfunction u...
Detailed Description
1\. BACKGROUND 1.1. RENAL DYSFUNCTION AND OPEN HEART SURGERY: The incidences of both cardiovascular disease (CVD) and chronic renal dysfunction (RD) are increasing with the aging population in the w...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Diagnosis of SCr \> 180 µmol/L or 2.0 mg/dL, and/or a GFR \< 30 mL/min/1.73 m2.
- Indication for elective open heart surgery under CPB.
Exclusion
- History of chronic or recent HD.
- Emergency status.
- Off-pump surgery.
- Failure to obtain patient consent documented by a signed consent form.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00720967
Start Date
November 1 2008
End Date
November 1 2012
Last Update
July 23 2008
Active Locations (7)
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1
University of Lyon, Hopital Cardiothoracique Louis Pradel
Lyon, France
2
German Heart Institute Berlin
Berlin, Germany, D-13353
3
Hospital Clinico, University of Barcelona, Department of Cardiovascular Surgery
Barcelona, Spain
4
University Hospital of Geneva, Service for Cardiovascular Surgery
Geneva, Switzerland, 1211