Back to resultsExamine the Effects of Maintaining Body Core Temperature During CABGs
Primary Purpose
Anesthesia, Hypothermia, Coronary Artery Bypass Grafting
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Allon Thermowrap. MTRE Advanced Technologies Ltd.
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia focused on measuring Hypothermia/complications/etiology, coronary artery bypass/adverse effects
Eligibility Criteria
Inclusion Criteria:
- Isolated on pump CABGs
- Age 18 - 85
- Preoperative core temperature 36- 37.5 °C
Exclusion Criteria:
- History of fever in the last week
- Severe renal, hepatic,hematologic or pulmonary disease
- Chronic Atrial fibrillation
- History of acute MI in the last week
- Previous neurologic abnormalities
Sites / Locations
- Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1 Thermo
2 Control
Arm Description
Outcomes
Primary Outcome Measures
Rate of atrial fibrillation
Rate of acute renal failure
Secondary Outcome Measures
Rate of Myocardial infarction and low output syndrome
Rate of Type I neurological injury
Total units of RBCs transfused
Length of mechanical ventilation
Rate of in-hospital mortality
Intensive Care Unit length of stay
Hospital length of stay
Cardiac Troponin I (cTnI) curve
Full Information
NCT ID
NCT00791050
First Posted
November 13, 2008
Last Updated
November 13, 2008
Sponsor
Centro Cardiologico Monzino
1. Study Identification
Unique Protocol Identification Number
NCT00791050
Brief Title
Examine the Effects of Maintaining Body Core Temperature During CABGs
Official Title
To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Centro Cardiologico Monzino
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although data on cardioprotective effects (as profile of troponin I)of perioperative maintenance of normothermia during CABGs are already known, little is known about the effects of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery. Being acute renal failure (ARF) and atrial fibrillation (AF) the two most frequent complications of this surgery, this study compare as primary end point the rate of postoperative ARF and AF in two group of patients, one actively warmed with Thermowrap and the control group receiving standard institutional care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Hypothermia, Coronary Artery Bypass Grafting
Keywords
Hypothermia/complications/etiology, coronary artery bypass/adverse effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 Thermo
Arm Type
Experimental
Arm Title
2 Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Allon Thermowrap. MTRE Advanced Technologies Ltd.
Intervention Description
Thermowrap set at 37 °C before induction of anesthesia and maintained until initiation of CPB; during CPB set to "monitoring" and set again to 37 °C from rewarming during CPB to end of surgery.
Primary Outcome Measure Information:
Title
Rate of atrial fibrillation
Time Frame
First 48 postoperative hours
Title
Rate of acute renal failure
Time Frame
First 48 postoperative hours
Secondary Outcome Measure Information:
Title
Rate of Myocardial infarction and low output syndrome
Time Frame
First postoperative 48 hours
Title
Rate of Type I neurological injury
Time Frame
First 48 postoperative hours
Title
Total units of RBCs transfused
Time Frame
First 48 postoperative hours
Title
Length of mechanical ventilation
Time Frame
First 48 postoperative hours
Title
Rate of in-hospital mortality
Time Frame
30 postoperative days
Title
Intensive Care Unit length of stay
Time Frame
30 postoperative days
Title
Hospital length of stay
Time Frame
30 postoperative days
Title
Cardiac Troponin I (cTnI) curve
Time Frame
First postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Isolated on pump CABGs
Age 18 - 85
Preoperative core temperature 36- 37.5 °C
Exclusion Criteria:
History of fever in the last week
Severe renal, hepatic,hematologic or pulmonary disease
Chronic Atrial fibrillation
History of acute MI in the last week
Previous neurologic abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Salvi, MD
Organizational Affiliation
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
City
Milano
Country
Italy
Facility Contact:
Phone
+ 39 02 58002541
Email
anestesisti@ccfm.it
First Name & Middle Initial & Last Name & Degree
Luca Salvi, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
12538173
Citation
Nesher N, Zisman E, Wolf T, Sharony R, Bolotin G, David M, Uretzky G, Pizov R. Strict thermoregulation attenuates myocardial injury during coronary artery bypass graft surgery as reflected by reduced levels of cardiac-specific troponin I. Anesth Analg. 2003 Feb;96(2):328-35, table of contents. doi: 10.1097/00000539-200302000-00007.
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Examine the Effects of Maintaining Body Core Temperature During CABGs
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