Examine the Effects of Maintaining Body Core Temperature During CABGs
To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2008
CompletedFirst Posted
Study publicly available on registry
November 14, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedNovember 14, 2008
October 1, 2008
1 year
November 13, 2008
November 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of atrial fibrillation
First 48 postoperative hours
Rate of acute renal failure
First 48 postoperative hours
Secondary Outcomes (8)
Rate of Myocardial infarction and low output syndrome
First postoperative 48 hours
Rate of Type I neurological injury
First 48 postoperative hours
Total units of RBCs transfused
First 48 postoperative hours
Length of mechanical ventilation
First 48 postoperative hours
Rate of in-hospital mortality
30 postoperative days
- +3 more secondary outcomes
Study Arms (2)
1 Thermo
EXPERIMENTAL2 Control
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- Isolated on pump CABGs
- Age 18 - 85
- Preoperative core temperature 36- 37.5 °C
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
Milan, Italy
Related Publications (1)
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.
PMID: 12538173BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Salvi, MD
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 13, 2008
First Posted
November 14, 2008
Study Start
January 1, 2009
Primary Completion
January 1, 2010
Study Completion
March 1, 2010
Last Updated
November 14, 2008
Record last verified: 2008-10