Examine the Effects of Maintaining Body Core Temperature During CABGs

November 13, 2008 updated by: Centro Cardiologico Monzino

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
        • Contact:
        • Principal Investigator:
          • Luca Salvi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Thermo
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.
No Intervention: 2 Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of atrial fibrillation
Time Frame: First 48 postoperative hours
First 48 postoperative hours
Rate of acute renal failure
Time Frame: First 48 postoperative hours
First 48 postoperative hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of Myocardial infarction and low output syndrome
Time Frame: First postoperative 48 hours
First postoperative 48 hours
Rate of Type I neurological injury
Time Frame: First 48 postoperative hours
First 48 postoperative hours
Total units of RBCs transfused
Time Frame: First 48 postoperative hours
First 48 postoperative hours
Length of mechanical ventilation
Time Frame: First 48 postoperative hours
First 48 postoperative hours
Rate of in-hospital mortality
Time Frame: 30 postoperative days
30 postoperative days
Intensive Care Unit length of stay
Time Frame: 30 postoperative days
30 postoperative days
Hospital length of stay
Time Frame: 30 postoperative days
30 postoperative days
Cardiac Troponin I (cTnI) curve
Time Frame: First postoperative 24 hours
First postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Investigators

  • Principal Investigator: Luca Salvi, MD, Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Estimate)

November 14, 2008

Last Update Submitted That Met QC Criteria

November 13, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCMAneste002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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