Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Preop Hemodialysis or Intraop Ultrafiltration for Patients With Severe Renal Dysfunction Undergoing Open Heart Surgery (SeRenaD-CPB)
This study is not yet open for participant recruitment.
Verified by University Hospital, Geneva, July 2008
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
  Purpose

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

MedlinePlus related topics: Dialysis Heart Surgery Kidney Failure
Drug Information available for: Iodine Cadexomer iodine Heparin Potassium chloride Protamine Benzocaine
U.S. FDA Resources
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

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Operative mortality, defined as any death occurring within 30 days after the operation or any death occurring before discharge during the same hospitalization (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival at one year after surgery (in percentage). [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
  • Postoperative low cardiac output (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative permanent neurological deficit (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative transient neurological deficit (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative acute renal dysfunction (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative persistent renal dysfunction requiring hemodialysis (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative gastrointestinal complication (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative respiratory failure (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative systemic infection (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative local infection (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative new-onset arrythmia (in percentage). [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative surgical drainage (in mL). [ Time Frame: within the first 72 hours after surgery ] [ Designated as safety issue: No ]
  • Postoperative need for transfusion of blood products (in unit packs). [ Time Frame: within the first 72 hours after surgery ] [ Designated as safety issue: No ]
  • Postoperative length of ICU stay (in days) [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Postoperative length of hospital stay (in days) [ Time Frame: within the first 30 days after surgery or before the discharge after surgery ] [ Designated as safety issue: No ]
  • Total hospital costs for the admission of operation (in Euros) [ Time Frame: From the day of admission to hospital until the day of discharge after surgery ] [ Designated as safety issue: No ]

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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • History of chronic or recent HD.
  • Emergency status.
  • Off-pump surgery.
  • Failure to obtain patient consent documented by a signed consent form.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720967

Contacts
Contact: Erman Pektok, MD +41.76.3169990 epektok@hotmail.com
Contact: Patrick O. Myers, MD +41.22.3727630 patrick.myers@hcuge.ch

Locations
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
Sponsors and Collaborators
University Hospital, Geneva
University of Gaziantep
Ankara University
Pamukkale University
German Heart Institute
University Hospital, Lyon, France
Hospital Clinic of Barcelona
Investigators
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
  More Information

Publications:
Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23. Review.
Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. Review.
Levin A, Foley RN. Cardiovascular disease in chronic renal insufficiency. Am J Kidney Dis. 2000 Dec;36(6 Suppl 3):S24-30. Review.
Anderson RJ, O'brien M, MaWhinney S, VillaNueva CB, Moritz TE, Sethi GK, Henderson WG, Hammermeister KE, Grover FL, Shroyer AL. Renal failure predisposes patients to adverse outcome after coronary artery bypass surgery. VA Cooperative Study #5. Kidney Int. 1999 Mar;55(3):1057-62.
Cooper WA, O'Brien SM, Thourani VH, Guyton RA, Bridges CR, Szczech LA, Petersen R, Peterson ED. Impact of renal dysfunction on outcomes of coronary artery bypass surgery: results from the Society of Thoracic Surgeons National Adult Cardiac Database. Circulation. 2006 Feb 28;113(8):1063-70. Epub 2006 Feb 20.
Zakeri R, Freemantle N, Barnett V, Lipkin GW, Bonser RS, Graham TR, Rooney SJ, Wilson IC, Cramb R, Keogh BE, Pagano D. Relation between mild renal dysfunction and outcomes after coronary artery bypass grafting. Circulation. 2005 Aug 30;112(9 Suppl):I270-5.
Weerasinghe A, Hornick P, Smith P, Taylor K, Ratnatunga C. Coronary artery bypass grafting in non-dialysis-dependent mild-to-moderate renal dysfunction. J Thorac Cardiovasc Surg. 2001 Jun;121(6):1083-9.
Ibáñez J, Riera M, Saez de Ibarra JI, Carrillo A, Fernández R, Herrero J, Fiol M, Bonnin O. Effect of preoperative mild renal dysfunction on mortality and morbidity following valve cardiac surgery. Interact Cardiovasc Thorac Surg. 2007 Dec;6(6):748-52. Epub 2007 Sep 21.
Filsoufi F, Rahmanian PB, Castillo JG, Chikwe J, Carpentier A, Adams DH. Early and late outcomes of cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis. Interact Cardiovasc Thorac Surg. 2008 Feb;7(1):90-5. Epub 2007 Nov 22.
Devbhandari MP, Duncan AJ, Grayson AD, Fabri BM, Keenan DJ, Bridgewater B, Jones MT, Au J; North West Quality Improvement Programme in Cardiac Interventions. Effect of risk-adjusted, non-dialysis-dependent renal dysfunction on mortality and morbidity following coronary artery bypass surgery: a multi-centre study. Eur J Cardiothorac Surg. 2006 Jun;29(6):964-70. Epub 2006 May 3.
Kilo J, Margreiter JE, Ruttmann E, Laufer G, Bonatti JO. Slightly elevated serum creatinine predicts renal failure requiring hemofiltration after cardiac surgery. Heart Surg Forum. 2005;8(1):E34-8.
Mangano CM, Diamondstone LS, Ramsay JG, Aggarwal A, Herskowitz A, Mangano DT. Renal dysfunction after myocardial revascularization: risk factors, adverse outcomes, and hospital resource utilization. The Multicenter Study of Perioperative Ischemia Research Group. Ann Intern Med. 1998 Feb 1;128(3):194-203.
Shen I, Giacomuzzi C, Ungerleider RM. Current strategies for optimizing the use of cardiopulmonary bypass in neonates and infants. Ann Thorac Surg. 2003 Feb;75(2):S729-34.
Naik SK, Knight A, Elliott MJ. A successful modification of ultrafiltration for cardiopulmonary bypass in children. Perfusion. 1991;6(1):41-50.
Naik SK, Knight A, Elliott M. A prospective randomized study of a modified technique of ultrafiltration during pediatric open-heart surgery. Circulation. 1991 Nov;84(5 Suppl):III422-31.
Luciani GB, Menon T, Vecchi B, Auriemma S, Mazzucco A. Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial. Circulation. 2001 Sep 18;104(12 Suppl 1):I253-9.
Boodhwani M, Williams K, Babaev A, Gill G, Saleem N, Rubens FD. Ultrafiltration reduces blood transfusions following cardiac surgery: A meta-analysis. Eur J Cardiothorac Surg. 2006 Dec;30(6):892-7. Epub 2006 Oct 13. Review.
Bogă M, Islamoğlu, Badak I, Cikirikçioğlu M, Bakalim T, Yağdi T, Büket S, Hamulu A. The effects of modified hemofiltration on inflammatory mediators and cardiac performance in coronary artery bypass grafting. Perfusion. 2000 Mar;15(2):143-50.
Capuano F, Bianchini R, Goracci M, Roscitano A, Luciani R, Simon C, Giusti L, Sinatra R. Intraoperative veno-arterial hemofiltration during miniaturized extracorporeal bypass. Ann Thorac Surg. 2007 Jun;83(6):2215-6.
Durmaz I, Yagdi T, Calkavur T, Mahmudov R, Apaydin AZ, Posacioglu H, Atay Y, Engin C. Prophylactic dialysis in patients with renal dysfunction undergoing on-pump coronary artery bypass surgery. Ann Thorac Surg. 2003 Mar;75(3):859-64.
Bingol H, Akay HT, Iyem H, Bolcal C, Oz K, Sirin G, Demirkilic U, Tatar H. Prophylactic dialysis in elderly patients undergoing coronary bypass surgery. Ther Apher Dial. 2007 Feb;11(1):30-5.
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.

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

Keywords provided by University Hospital, Geneva:
Renal dysfunction
Hemodialysis
Modified ultrafiltration
Open heart surgery

Study placed in the following topic categories:
Benzocaine
Iodine
Protamines
Heparin
Calcium heparin

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009