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

Primary Purpose

Coronary Artery Disease, Coronary Artery Bypass, Erythrocyte Transfusion

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Fluid Restriction Policy
Free fluid infusion
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Allogenic Blood Use, Total Blood Loss, Reinfusion of Washed Shed Blood

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Larissa University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RESTRICTED FLUIDS

FREE FLUIDS

Arm Description

Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass

Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass

Outcomes

Primary Outcome Measures

Mean Number of Packed Red Cells Units Transfused During Hospital Stay

Secondary Outcome Measures

Full Information

First Posted
January 14, 2008
Last Updated
May 9, 2011
Sponsor
Larissa University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00600704
Brief Title
Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery
Official Title
Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Larissa University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Bypass, Erythrocyte Transfusion
Keywords
Allogenic Blood Use, Total Blood Loss, Reinfusion of Washed Shed Blood

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RESTRICTED FLUIDS
Arm Type
Active Comparator
Arm Description
Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass
Arm Title
FREE FLUIDS
Arm Type
Active Comparator
Arm Description
Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass
Intervention Type
Procedure
Intervention Name(s)
Fluid Restriction Policy
Intervention Description
Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass
Intervention Type
Procedure
Intervention Name(s)
Free fluid infusion
Intervention Description
Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Mean Number of Packed Red Cells Units Transfused During Hospital Stay
Time Frame
20 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ATHINA KLEITSAKI, Dr
Organizational Affiliation
Larissa University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
GEORGE VRETZAKIS, M.D. PhD
Organizational Affiliation
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
KONSTANTINOS STAMOULIS, M.D.
Organizational Affiliation
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
CHRISTOS DRAGOUMANIS, M.D. PhD
Organizational Affiliation
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
VASILIOS TASOUDIS, M.D.
Organizational Affiliation
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
KATERINA KYRIAKAKI, M.D.
Organizational Affiliation
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
DEMETRIOS MIKROULIS, M.D. PhD
Organizational Affiliation
Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ATHANASIOS GIANNOUKAS, MD MSc PhD
Organizational Affiliation
Department of Vascular Surgery, University Hospital of Larissa, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
NIKOLAOS TSILIMINGAS, M.D. PhD
Organizational Affiliation
Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece
Official's Role
Study Chair
Facility Information:
Facility Name
Larissa University Hospital
City
Larissa
State/Province
Thesalia
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
17462454
Citation
Society of Thoracic Surgeons Blood Conservation Guideline Task Force; Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, Bridges CR, Higgins RS, Despotis G, Brown JR; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion; Spiess BD, Shore-Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007 May;83(5 Suppl):S27-86. doi: 10.1016/j.athoracsur.2007.02.099.
Results Reference
background
PubMed Identifier
16153909
Citation
Dial S, Delabays E, Albert M, Gonzalez A, Camarda J, Law A, Menzies D. Hemodilution and surgical hemostasis contribute significantly to transfusion requirements in patients undergoing coronary artery bypass. J Thorac Cardiovasc Surg. 2005 Sep;130(3):654-61. doi: 10.1016/j.jtcvs.2005.02.025.
Results Reference
background
PubMed Identifier
9477051
Citation
Stover EP, Siegel LC, Parks R, Levin J, Body SC, Maddi R, D'Ambra MN, Mangano DT, Spiess BD. Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the Multicenter Study of Perioperative Ischemia Research Group. Anesthesiology. 1998 Feb;88(2):327-33. doi: 10.1097/00000542-199802000-00009.
Results Reference
background
PubMed Identifier
16181875
Citation
Karkouti K, Djaiani G, Borger MA, Beattie WS, Fedorko L, Wijeysundera D, Ivanov J, Karski J. Low hematocrit during cardiopulmonary bypass is associated with increased risk of perioperative stroke in cardiac surgery. Ann Thorac Surg. 2005 Oct;80(4):1381-7. doi: 10.1016/j.athoracsur.2005.03.137.
Results Reference
background
PubMed Identifier
12830066
Citation
Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ, Shah A. Adverse effects of low hematocrit during cardiopulmonary bypass in the adult: should current practice be changed? J Thorac Cardiovasc Surg. 2003 Jun;125(6):1438-50. doi: 10.1016/s0022-5223(02)73291-1.
Results Reference
background
PubMed Identifier
11269449
Citation
DeFoe GR, Ross CS, Olmstead EM, Surgenor SD, Fillinger MP, Groom RC, Forest RJ, Pieroni JW, Warren CS, Bogosian ME, Krumholz CF, Clark C, Clough RA, Weldner PW, Lahey SJ, Leavitt BJ, Marrin CA, Charlesworth DC, Marshall P, O'Connor GT. Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting. Northern New England Cardiovascular Disease Study Group. Ann Thorac Surg. 2001 Mar;71(3):769-76. doi: 10.1016/s0003-4975(00)02393-6.
Results Reference
background
PubMed Identifier
20181257
Citation
Vretzakis G, Kleitsaki A, Stamoulis K, Bareka M, Georgopoulou S, Karanikolas M, Giannoukas A. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial. J Cardiothorac Surg. 2010 Feb 24;5:7. doi: 10.1186/1749-8090-5-7.
Results Reference
derived
PubMed Identifier
20187484
Citation
Vretzakis G, Kleitsaki A, Stamoulis K, Dragoumanis C, Tasoudis V, Kyriakaki K, Mikroulis D, Giannoukas A, Tsilimingas N. The impact of fluid restriction policy in reducing the use of red blood cells in cardiac surgery. Acta Anaesthesiol Belg. 2009;60(4):221-8.
Results Reference
derived

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

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