Clinical trial NCT00600704: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Bypass
Erythrocyte Transfusion
Keywords: Allogenic Blood Use
Total Blood Loss
Reinfusion of Washed Shed Blood
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Mean Number of Packed Red Cells Units Transfused During Hospital Stay
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
state: Thesalia
Study officials:
affiliation: Larissa University Hospital
name: ATHINA KLEITSAKI, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: GEORGE VRETZAKIS, M.D. PhD
role: STUDY_DIRECTOR
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: KONSTANTINOS STAMOULIS, M.D.
role: STUDY_CHAIR
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: CHRISTOS DRAGOUMANIS, M.D. PhD
role: STUDY_CHAIR
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: VASILIOS TASOUDIS, M.D.
role: STUDY_CHAIR
affiliation: Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
name: KATERINA KYRIAKAKI, M.D.
role: STUDY_CHAIR
affiliation: Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece
name: DEMETRIOS MIKROULIS, M.D. PhD
role: STUDY_CHAIR
affiliation: Department of Vascular Surgery, University Hospital of Larissa, Greece
name: ATHANASIOS GIANNOUKAS, MD MSc PhD
role: STUDY_CHAIR
affiliation: Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece
name: NIKOLAOS TSILIMINGAS, M.D. PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.