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

Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Artery Bypass; Erythrocyte Transfusion
• Intervention / Treatment: Procedure: Fluid Restriction Policy; Procedure: Free fluid infusion

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thesalia
    • Larissa, Thesalia, Greece, 41110
      • Larissa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Number of Packed Red Cells Units Transfused During Hospital Stay	20 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: January 24, 2008
• First Posted (Estimate): January 25, 2008

Study Record Updates

• Last Update Posted (Estimate): June 7, 2011
• Last Update Submitted That Met QC Criteria: May 9, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Allogenic Blood Use; Total Blood Loss; Reinfusion of Washed Shed Blood
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: LUH 1975 AK; POL 1969 TT