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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600704
• Other study ID #: LUH 1975 AK
• Secondary ID: POL 1969 TT
• Status: Completed
• Phase: N/A
• First received: January 14, 2008
• Last updated: May 9, 2011
• Start date: November 2007
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: Ministry of Health and WelfareGreece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Coronary Artery Disease
• Coronary Disease
• Erythrocyte Transfusion
• Myocardial Ischemia

Intervention

Procedure:
• Fluid Restriction Policy
Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass
• Free fluid infusion
Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass

Locations

Country	Name	City	State
Greece	Larissa University Hospital	Larissa	Thesalia

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Packed Red Cells Units Transfused During Hospital Stay		20 months	Yes