![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
University Hospital, Geneva University of Gaziantep Ankara University Pamukkale University German Heart Institute University Hospital, Lyon, France Hospital Clinic of Barcelona |
---|---|
Information provided by: | University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT00720967 |
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 undergoing open heart surgery.
Condition | Intervention | Phase |
---|---|---|
Non-Dialysis Dependent Severe Renal Dysfunction Cardiovascular Disease |
Procedure: Open Heart Surgery (OHS) Procedure: Intraoperative Modified Ultrafiltration (MUF) Procedure: Hemodialysis (HD) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Influence of Preoperative Hemodialysis or Intraoperative Modified Ultrafiltration on Postoperative Outcome for Patients With Severe Renal Dysfunction Undergoing Open Heart Surgery: Randomized, Controlled, Multicenter Clinical Trial |
Estimated Enrollment: | 450 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Control Group (Open heart surgery alone)
|
Procedure: Open Heart Surgery (OHS)
General anesthesia, use of iodine impregnated adhesive dressing, median sternotomy and/or thoracotomy incision, full heparinization (300-400 ui/kg), arterial and venous cannulation, initialization of CPB with or without aortic cross-clamping and high-potassium cold cardioplegia, surgical repair under mild-moderate hypothermia. De-clamping (if cross clamp was applied), neutralization of heparin by protamin, de-cannulation and hemostasis after surgical repair. Insertion of drain(s) and pacing wire(s). Closure of all layers in anatomical plan.
|
2: Experimental
Intraoperative Modified Ultrafiltration (MUF) Group (Open heart surgery with intraoperative MUF)
|
Procedure: Open Heart Surgery (OHS)
General anesthesia, use of iodine impregnated adhesive dressing, median sternotomy and/or thoracotomy incision, full heparinization (300-400 ui/kg), arterial and venous cannulation, initialization of CPB with or without aortic cross-clamping and high-potassium cold cardioplegia, surgical repair under mild-moderate hypothermia. De-clamping (if cross clamp was applied), neutralization of heparin by protamin, de-cannulation and hemostasis after surgical repair. Insertion of drain(s) and pacing wire(s). Closure of all layers in anatomical plan.
Procedure: Intraoperative Modified Ultrafiltration (MUF)
Once the surgical repair is finished, and CPB will be stopped after aortic declamping. The arterial and venous cannulae will be connected to each other using 3-way connectors and a cardioplegia line. When hemodynamic stability is established (MAP >75 mmHg, CVP > 12 mmHg, Htc > 25%), blood will be drained from the arterial cannula using a roller pump, driven to the ultrafilter, and eventually to the venous cannula. The blood flow will be maintained at ~150 mL/min, and suction will be applied to the filtrate port to achieve an ultrafiltration of 100-120 mL/min. Heat exchanger and bubble trap of the cardioplegia line will be used to maintain the filtered blood at body temperature and to prevent air embolism, respectively. MUF will continue 20 minutes. The filtered volume will be collected.
|
3: Experimental
Preoperative Hemodialysis Group (Open Heart Surgery after preoperative hemodialysis)
|
Procedure: Open Heart Surgery (OHS)
General anesthesia, use of iodine impregnated adhesive dressing, median sternotomy and/or thoracotomy incision, full heparinization (300-400 ui/kg), arterial and venous cannulation, initialization of CPB with or without aortic cross-clamping and high-potassium cold cardioplegia, surgical repair under mild-moderate hypothermia. De-clamping (if cross clamp was applied), neutralization of heparin by protamin, de-cannulation and hemostasis after surgical repair. Insertion of drain(s) and pacing wire(s). Closure of all layers in anatomical plan.
Procedure: Hemodialysis (HD)
Two HD sessions will be performed at 3 days and 1 day prior to surgery. Each session will last 3 hours if the patient weighs < 75 kg, and 4 hours if > 75 kg. Conventional HD will be carried out using a volume-controlled dialysis machine. A bicarbonate dialysate containing K (3 mmol/L), Ca (1.5 mmol/L) and HCO3 (31 mmol/L) will be used. Sodium conductivity will be set at 138 mmol/L. Medium-flow filters will be used as artificial kidney devices. Dialysate temperature will be set at 36oC. Dialysate and blood flow rate will be set at 500 mL/min and 250-300 ml/min, respectively. Intradialytic ultrafiltration will not be used routinely unless the patient has volume overload. The decision to use intradialytic ultrafiltration will be taken with the anaesthesiologist and the cardiac surgeon. If intradialytic ultrafiltration is indicated, maximal rate of ultrafiltration will be 10 ml/kg/hour. These patients will undergo open heart surgery after two sessions of HD.
|
Ages Eligible for Study: | 18 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erman Pektok, MD | +41.76.3169990 | epektok@hotmail.com |
Contact: Patrick O. Myers, MD | +41.22.3727630 | patrick.myers@hcuge.ch |
France | |
University of Lyon, Hopital Cardiothoracique Louis Pradel | |
Lyon, France | |
Germany | |
German Heart Institute Berlin | |
Berlin, Germany, D-13353 | |
Spain | |
Hospital Clinico, University of Barcelona, Department of Cardiovascular Surgery | |
Barcelona, Spain | |
Switzerland | |
University Hospital of Geneva, Service for Cardiovascular Surgery | |
Geneva, Switzerland, 1211 | |
Turkey | |
Gaziantep University, Department of Cardiovascular Surgery | |
Gaziantep, Turkey, 27310 | |
Ankara University, Department of Cardiovascular Surgery | |
Ankara, Turkey, 06340 | |
Pamukkale University, Department of Cardiovascular Surgery | |
Denizli, Turkey, 20070 |
Principal Investigator: | Erman Pektok, MD | University Hospital of Geneva, Service for Cardiovascular Surgery |
Study Director: | Patrick O Myers, MD | University Hospital of Geneva, Service for Cardiovascular Surgery |
Study Director: | Thomas Perneger, MD, PhD | University Hospital of Geneva, Center of Clinical Research |
Study Chair: | Afksendiyos Kalangos, MD, PhD | University Hospital of Geneva, Service for Cardiovascular Surgery |
Responsible Party: | University Hospital of Geneva, Service for Cardiovascular Surgery ( Erman Pektok, MD ) |
Study ID Numbers: | 08-058 (NAC 08018) |
Study First Received: | July 21, 2008 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00720967 |
Health Authority: | Switzerland: Ethikkommission; Turkey: Ethics Committee; Germany: Ethics Commission; France: Institutional Ethical Committee; Spain: Ethics Committee |
Renal dysfunction Hemodialysis Modified ultrafiltration Open heart surgery |
Benzocaine Iodine Protamines Heparin Calcium heparin |
Cardiovascular Diseases |