Coronary Artery DiseaseNCT00600704
Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery
A study testing Fluid Restriction Policy and Free fluid infusion in people with Coronary Artery Disease and Coronary Artery Bypass, run by Larissa University Hospital at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass, Erythrocyte Transfusion
- What is being tested?
- Fluid Restriction Policy and Free fluid infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ejection fraction (EF) of left ventricle (LV) > 35%
- Preoperative serum Creatinine < 150 μmol/l
- Preoperative Haemoglobin > 10/dl
- Peripheral anastomosis scheduled =< 3
Who cannot join
- 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%
Show all 11Show fewer
- CVA
- INR > 1.5
- chronic obstructive pulmonary disease (COPD)
- Steroid therapy-chronic inflammatory process
- Use of aprotinin or tranexamic acid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Fluid Restriction Policy, Free fluid infusion
- Keywords
- Allogenic Blood Use, Total Blood Loss, Reinfusion of Washed Shed Blood
- Medical subject headings
- Coronary Artery Disease, Exsanguination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid Restriction PolicyProcedure or surgery
Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass
Free fluid infusionProcedure or surgery
Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| RESTRICTED FLUIDS | Active comparator | Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass Receives: Procedure: Fluid Restriction Policy |
| FREE FLUIDS | Active comparator | Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass Receives: Procedure: Free fluid infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Packed Red Cells Units Transfused During Hospital Stay
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2008
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- ATHINA KLEITSAKI, Dr, Principal investigator, Larissa University HospitalGEORGE VRETZAKIS, M.D. PhD, Study director, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, GreeceKONSTANTINOS STAMOULIS, M.D., Study chair, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, GreeceCHRISTOS DRAGOUMANIS, M.D. PhD, Study chair, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, GreeceVASILIOS TASOUDIS, M.D., Study chair, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, GreeceKATERINA KYRIAKAKI, M.D., Study chair, Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, GreeceDEMETRIOS MIKROULIS, M.D. PhD, Study chair, Department of Cardiothoracic Surgery, University Hospital of Larissa, GreeceATHANASIOS GIANNOUKAS, MD MSc PhD, Study chair, Department of Vascular Surgery, University Hospital of Larissa, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600704
- Sponsor's protocol ID
- LUH 1975 AK
- Other IDs
- POL 1969 TT
- Status last verified
- Mar 2011
- First submitted
- 14 Jan 2008
- Last updated
- 7 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 17462454Dial 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.
PubMed 16153909Stover 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.
PubMed 9477051Karkouti 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.
PubMed 16181875Habib 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.
PubMed 12830066DeFoe 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.
PubMed 11269449Vretzakis 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.
PubMed 20187484Vretzakis 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.
PubMed 20181257
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00600704
- Acronym / sponsor ID
- LUH 1975 AK
- Keywords
- Allogenic Blood Use, Total Blood Loss, Reinfusion of Washed Shed Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Posted 7 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESTRICTED FLUIDS | Active comparator | Procedure: Fluid Restriction PolicyInfusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass |
| FREE FLUIDS | Active comparator | Procedure: Free fluid infusionFree fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Ejection fraction (EF) of left ventricle (LV) > 35%
- Preoperative serum Creatinine < 150 μmol/l
- Preoperative Haemoglobin > 10/dl
- Peripheral anastomosis scheduled =< 3
Key exclusion criteria (11 listed)
- redo bypass-emergency operations
- prior coronal stenting
- active congestive heart failure
- documented Myocardial Infraction within the previous 6 weeks
- NYHA class > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid Restriction PolicyInfusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass | Procedure or surgery | RESTRICTED FLUIDS |
| Free fluid infusionFree fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass | Procedure or surgery | FREE FLUIDS |
Primary outcome
Mean Number of Packed Red Cells Units Transfused During Hospital Stay
Time frame: 20 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17462454Society 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.
- Background: PubMed 16153909Dial 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.
- Background: PubMed 9477051Stover 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.
- Background: PubMed 16181875Karkouti 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.
- Background: PubMed 12830066Habib 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.
- Background: PubMed 11269449DeFoe 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.
- Derived from this study: PubMed 20187484Vretzakis 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.
- Derived from this study: PubMed 20181257Vretzakis 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.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ATHINA KLEITSAKI, Dr principal investigator
Larissa University Hospital
GEORGE VRETZAKIS, M.D. PhD study director
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
KONSTANTINOS STAMOULIS, M.D. study chair
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Restriction Policy and Free fluid infusion in people with Coronary Artery Disease and Coronary Artery Bypass, run by Larissa University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Packed Red Cells Units Transfused During Hospital Stay (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600704, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2011.