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

NCT00600704 | Completed Results

• 2 other identifiers: LUH 1975 AKPOL 1969 TT
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass; Erythrocyte Transfusion

Keywords

Allogenic Blood Use; Total Blood Loss; Reinfusion of Washed Shed Blood

Outcome Measures

Primary Outcomes (1)

• Mean Number of Packed Red Cells Units Transfused During Hospital Stay

  20 months

Study Arms (2)

RESTRICTED FLUIDS

ACTIVE COMPARATOR

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

Procedure: Fluid Restriction Policy

FREE FLUIDS

ACTIVE COMPARATOR

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

Procedure: Free fluid infusion

Interventions

Fluid Restriction Policy PROCEDURE

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

RESTRICTED FLUIDS

Free fluid infusion PROCEDURE

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

FREE FLUIDS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (1)

Larissa University Hospital

Larissa, Thesalia, 41110, Greece

Location

Related Publications (8)

• 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.

  PMID: 17462454 BACKGROUND

• 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.

  PMID: 16153909 BACKGROUND

• 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.

  PMID: 9477051 BACKGROUND

• 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.

  PMID: 16181875 BACKGROUND

• 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.

  PMID: 12830066 BACKGROUND

• 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.

  PMID: 11269449 BACKGROUND

• 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.

  PMID: 20187484 DERIVED

• 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.

  PMID: 20181257 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Exsanguination

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Athina Kleitsaki
• Organization: Larissa University Hospital Dept. of Anesthesiology

theoath1@gmail.com

00306948481865

Study Officials

• ATHINA KLEITSAKI, Dr

  Larissa University Hospital

  PRINCIPAL INVESTIGATOR

• GEORGE VRETZAKIS, M.D. PhD

  Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: March 1, 2011
• Last Updated: June 7, 2011
• Results First Posted: June 7, 2011

Record last verified: 2011-03

Locations

GR (1)