AnesthesiaNCT00791050
Examine the Effects of Maintaining Body Core Temperature During CABGs
A study testing Allon Thermowrap. MTRE Advanced Technologies Ltd. in people with Anesthesia and Hypothermia, run by Centro Cardiologico Monzino at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anesthesia, Hypothermia, Coronary Artery Bypass Grafting
- What is being tested?
- Allon Thermowrap. MTRE Advanced Technologies Ltd.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated on pump CABGs
- Age 18 - 85
- Preoperative core temperature 36- 37.5 °C
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
Milan
+ 39 02 58002541, anestesisti@ccfm.it
Luca Salvi, MD
About this study
Official title: 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.
- Conditions
- Anesthesia, Hypothermia, Coronary Artery Bypass Grafting
- Being tested
- Allon Thermowrap. MTRE Advanced Technologies Ltd.
- Keywords
- Hypothermia/complications/etiology, coronary artery bypass/adverse effects
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allon Thermowrap. MTRE Advanced Technologies Ltd.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 Thermo | Experimental | Not described Receives: Device: Allon Thermowrap. MTRE Advanced Technologies Ltd. |
| 2 Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of atrial fibrillation
Measured: First 48 postoperative hours
Rate of acute renal failure
Measured: First 48 postoperative hours
Secondary outcomes (8)
Rate of Myocardial infarction and low output syndrome
Measured: First postoperative 48 hours
Rate of Type I neurological injury
Measured: First 48 postoperative hours
Total units of RBCs transfused
Measured: First 48 postoperative hours
Length of mechanical ventilation
Measured: First 48 postoperative hours
Rate of in-hospital mortality
Measured: 30 postoperative days
Intensive Care Unit length of stay
Measured: 30 postoperative days
Hospital length of stay
Measured: 30 postoperative days
Cardiac Troponin I (cTnI) curve
Measured: First postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Investigators
- Luca Salvi, MD, Principal investigator, Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791050
- Sponsor's protocol ID
- CCMAneste002
- Status last verified
- Oct 2008
- First submitted
- 13 Nov 2008
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12538173
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap
- ClinicalTrials.gov ID
- NCT00791050
- Acronym / sponsor ID
- CCMAneste002
- Conditions
- Anesthesia, Hypothermia, Coronary Artery Bypass Grafting
- Keywords
- Hypothermia/complications/etiology, coronary artery bypass/adverse effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Thermo | Experimental | Device: Allon Thermowrap. MTRE Advanced Technologies Ltd. |
| 2 Control | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated on pump CABGs
- Age 18 - 85
- Preoperative core temperature 36- 37.5 °C
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| 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. | Device | 1 Thermo |
Primary outcome
Rate of atrial fibrillation
Time frame: First 48 postoperative hours
Rate of acute renal failure
Time frame: First 48 postoperative hours
8 secondary outcomes
Rate of Myocardial infarction and low output syndrome
Time frame: First postoperative 48 hours
Rate of Type I neurological injury
Time frame: First 48 postoperative hours
Total units of RBCs transfused
Time frame: First 48 postoperative hours
Length of mechanical ventilation
Time frame: First 48 postoperative hours
Rate of in-hospital mortality
Time frame: 30 postoperative days
Intensive Care Unit length of stay
Time frame: 30 postoperative days
Hospital length of stay
Time frame: 30 postoperative days
Cardiac Troponin I (cTnI) curve
Time frame: First postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
- Background: PubMed 12538173Nesher 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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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.
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
Milan, Italy
Luca Salvi, MD principal investigator
Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allon Thermowrap. MTRE Advanced Technologies Ltd. in people with Anesthesia and Hypothermia, run by Centro Cardiologico Monzino at 1 site in Italy.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Nov 2008. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of atrial fibrillation (time frame: First 48 postoperative hours). The study lists 2 primary outcomes in all. 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 NCT00791050, which also lists 1 linked publication.
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 14 Nov 2008.