Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT00600704
First received: January 14, 2008
Last updated: May 9, 2011
Last verified: March 2011
  Purpose

The investigators' hypothesis is that restriction of circulating fluids in comparison to a liberal fluid administration policy would lead to a reduction of allogenic red blood cells exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery bypass graft supported by reinfusion of washed shed blood from thoracic cavities.


Condition Intervention
Coronary Artery Disease
Coronary Artery Bypass
Erythrocyte Transfusion
Procedure: Fluid Restriction Policy
Procedure: Free fluid infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Mean Number of Packed Red Cells Units Transfused During Hospital Stay [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: November 2007
Study Completion Date: March 2011
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RESTRICTED FLUIDS
Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass
Procedure: Fluid Restriction Policy
Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass
Active Comparator: FREE FLUIDS
Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass
Procedure: Free fluid infusion
Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass

Detailed Description:

192 patients operated under equal conditions were assigned prospectively and randomly either for a restrictive protocol for intravenous fluid administration (group A, 100 patients) or not (group B, 92 patients). Transfusion guidelines were common for the two groups. The volumes of intravenous fluids, priming, "extra" volume on pump and cardioplegic solution and the volume of urine were recorded. Net erythrocyte volume loss was calculated. The number of the transfused PRC was analyzed as a continuous variable. "Transfusion" was analyzed as a categorical characteristic. Analysis employed Student's two-tailed t-test, t-paired test and chitest.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ejection fraction (EF) of left ventricle (LV) > 35%
  • Preoperative serum Creatinine < 150 μmol/l
  • Preoperative Haemoglobin > 10/dl
  • Peripheral anastomosis scheduled =< 3

Exclusion Criteria:

  • redo bypass-emergency operations
  • prior coronal stenting
  • active congestive heart failure
  • documented Myocardial Infraction within the previous 6 weeks
  • NYHA class > 3
  • Carotid stenosis > 50%
  • CVA
  • INR > 1.5
  • chronic obstructive pulmonary disease (COPD)
  • Steroid therapy-chronic inflammatory process
  • Use of aprotinin or tranexamic acid
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600704

Locations
Greece
Larissa University Hospital
Larissa, Thesalia, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
Investigators
Principal Investigator: ATHINA KLEITSAKI, Dr Larissa University Hospital
Study Director: GEORGE VRETZAKIS, M.D. PhD Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Study Chair: KONSTANTINOS STAMOULIS, M.D. Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Study Chair: CHRISTOS DRAGOUMANIS, M.D. PhD Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Study Chair: VASILIOS TASOUDIS, M.D. Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Study Chair: KATERINA KYRIAKAKI, M.D. Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Study Chair: DEMETRIOS MIKROULIS, M.D. PhD Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece
Study Chair: ATHANASIOS GIANNOUKAS, MD MSc PhD Department of Vascular Surgery, University Hospital of Larissa, Greece
Study Chair: NIKOLAOS TSILIMINGAS, M.D. PhD Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ATHINA KLEITSAKI, LARISSA UNIVERSITY HOSPITAL/DPT OF ANESTHESIOLOGY
ClinicalTrials.gov Identifier: NCT00600704     History of Changes
Other Study ID Numbers: LUH 1975 AK, POL 1969 TT
Study First Received: January 14, 2008
Results First Received: March 4, 2011
Last Updated: May 9, 2011
Health Authority: Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines

Keywords provided by Larissa University Hospital:
Allogenic Blood Use
Total Blood Loss
Reinfusion of Washed Shed Blood

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014