Examine the Effects of Maintaining Body Core Temperature During CABGs

Anesthesia Clinical Trial

Official title:

To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00791050
• Other study ID #: CCMAneste002
• Status: Not yet recruiting
• Phase: N/A
• First received: November 13, 2008
• Last updated: November 13, 2008
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: October 2008
• Source: Centro Cardiologico Monzino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Coronary Artery Bypass Grafting
• Hypothermia

Intervention

Device:
• Allon Thermowrap. MTRE Advanced Technologies Ltd.
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.

Locations

Country	Name	City	State
Italy	Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of atrial fibrillation		First 48 postoperative hours	No
Primary	Rate of acute renal failure		First 48 postoperative hours	No
Secondary	Rate of Myocardial infarction and low output syndrome		First postoperative 48 hours	No
Secondary	Rate of Type I neurological injury		First 48 postoperative hours	No
Secondary	Total units of RBCs transfused		First 48 postoperative hours	No
Secondary	Length of mechanical ventilation		First 48 postoperative hours	No
Secondary	Rate of in-hospital mortality		30 postoperative days	No
Secondary	Intensive Care Unit length of stay		30 postoperative days	No
Secondary	Hospital length of stay		30 postoperative days	No
Secondary	Cardiac Troponin I (cTnI) curve		First postoperative 24 hours	No