Target Temperature Management After Cardiac Arrest (TTM)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Scandinavian Critical Care Trials Group

Copenhagen Trial Unit, Center for Clinical Intervention Research

Lund University

The George Institute of Global Health, Sydney, Australia

Information provided by (Responsible Party):

Niklas Nielsen, Helsingborgs Hospital

ClinicalTrials.gov Identifier:

NCT01020916

First received: November 25, 2009

Last updated: January 10, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 25, 2009

Last Updated Date

January 10, 2013

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

All-cause mortality [ Time Frame: Maximum follow-up with a minimum of 180 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

All-cause mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01020916 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Composite outcome of all-cause mortality and poor neurological function (CPC 3 and 4) and composite outcome of all-cause mortality and poor neurological function (modified Rankin Scale 4 and 5) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Bleeding [ Time Frame: During day 1-7 of intensive care treatment ] [ Designated as safety issue: Yes ]
Neurological function [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Cerebral Performance Category, Modified Rankin Scale
Pneumonia [ Time Frame: During day 1-7 of intensive care treatment ] [ Designated as safety issue: Yes ]
Electrolyte disorders [ Time Frame: During day 1-7 of intensive care treatment ] [ Designated as safety issue: Yes ]
Hyperglycaemia > 10 mmol/l [ Time Frame: During day 1-7 of intensive care treatment ] [ Designated as safety issue: Yes ]
Hypoglycemia < 3mmol/l [ Time Frame: During day 1-7 of intensive care treatment ] [ Designated as safety issue: Yes ]
Cardiac arrhythmia [ Time Frame: During day 1-7 of intensive care treatment ] [ Designated as safety issue: Yes ]
The need for renal replacement therapy [ Time Frame: During day 1-7 of intensive care treatment ] [ Designated as safety issue: Yes ]
Landmark all-cause mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Cerebral Performance Category (CPC) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
CPC 1,2,3,4,5
Modified Rankin Scale (mRS) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
mRS 1,2,3,4,5,6

Original Secondary Outcome Measures ^ICMJE

Composite outcome of all-cause mortality and poor neurological function (CPC 3 and 4) [ Time Frame: Hospital discharge and 180 days ] [ Designated as safety issue: No ]
Bleeding, pneumonia, sepsis, electrolyte disorders, hyperglycaemia, hypoglycaemia, cardiac arrhythmia and the need for renal replacement therapy. [ Time Frame: During intensive care treatment ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Quality of life [ Time Frame: 180 days ] [ Designated as safety issue: No ]
SF-36
Neurological function including "Complete neurological recovery"* [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Mini mental state exam (MMSE), Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) and two questions*

*Survivors with complete recovery defined by: MMSE ≥27 (or ≥19 on MMSE-Adult Lifestyle Functioning Interview by telephone interview), modified IQCODE ≤78, answer "No" to question 1a or "No" to question 1b, answer "Yes" to question 2.

1a. "In the last 2 weeks, did you require help from another person for your every day activities?" (If yes, 1b. "Is this a new situation following the heart arrest?") and 2. "Do you feel that you have made a complete mental recovery after your heart arrest?
Neurological function at hospital discharge and best neurological function during follow up period [ Time Frame: Hospital discharge and 1-180 days ] [ Designated as safety issue: No ]
CPC at hospital discharge and best CPC during the first 180 days after cardiac arrest

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Target Temperature Management After Cardiac Arrest

Official Title ^ICMJE

Target Temperature Management 33°C Versus 36°C After Out-of-hospital Cardiac Arrest, a Randomised, Parallel Groups, Assessor Blinded Clinical Trial

Brief Summary

Experimental studies and previous clinical trials suggest an improvement in mortality and neurological function with hypothermia after cardiac arrest. However, the accrued evidence is inconclusive and associated with risks of systematic error, design error and random error. Elevated body temperature after cardiac arrest is associated with a worse outcome. Previous trials did not treat elevated body temperature in the control groups. The optimal target temperature for post-resuscitation care is not known. The primary purpose with the TTM-trial is to evaluate if there are differences in all-cause mortality, neurological function and adverse events between a target temperature management at 33°C and 36°C for 24 hours following return of spontaneous circulation after cardiac arrest.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Out-of-hospital Cardiac Arrest

Intervention ^ICMJE

Procedure: Target temperature 36°C
In hospital target temperature management to achieve a core body temperature of 36°C for 24 hours
Procedure: Target Temperature 33°C
In hospital target temperature management to achieve a core body temperature of 33°C for 24 hours

Study Arm (s)

Experimental: Target Temperature 33°C
Intervention: Procedure: Target Temperature 33°C
Active Comparator: Target Temperature 36°C
Intervention: Procedure: Target temperature 36°C

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

950

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age ≥ 18 years old
Out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause
Return of spontaneous circulation (ROSC)
Unconsciousness (Glasgow Coma Score < 8) (patients not able to obey verbal commands)after sustained ROSC

Exclusion Criteria:

In-hospital cardiac arrest
OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
Known bleeding diathesis (medically induced coagulopathy (e.g warfarin, clopidogrel) does not exclude the patient).
Suspected or confirmed acute intracranial bleeding
Suspected or confirmed acute stroke
Unwitnessed asystole
Known limitations in therapy and Do Not Resuscitate-order
Known disease making 180 days survival unlikely
Known pre-arrest CPC 3 or 4
Temperature < 30°C on admission
> 4 hours (240 minutes) from ROSC to screening
Systolic blood pressure < 80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump#
- If the systolic blood pressure (SBP) is recovering during the inclusion window (220 minutes) the patient can be included.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Czech Republic, Denmark, Italy, Luxembourg, Netherlands, Norway, Sweden, Switzerland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01020916

Other Study ID Numbers ^ICMJE

TTM-1

Has Data Monitoring Committee

Yes

Responsible Party

Niklas Nielsen, Helsingborgs Hospital

Study Sponsor ^ICMJE

Niklas Nielsen

Collaborators ^ICMJE

Scandinavian Critical Care Trials Group
Copenhagen Trial Unit, Center for Clinical Intervention Research
Lund University
The George Institute of Global Health, Sydney, Australia

Investigators ^ICMJE

Study Chair:	Niklas Nielsen, MD, PhD	Helsingborgs lasarett, Region Skåne, Sweden
Principal Investigator:	Janneke Horn, MD, PhD	Academisch Medisch Centrum, Amsterdam, the Netherlands
Principal Investigator:	Hans Friberg, MD, PhD	Lund University Hospital, Lund, Sweden
Principal Investigator:	Tobias Cronberg, MD, PhD	Lund University Hospital, Lund, Sweden
Principal Investigator:	Michael Wanscher, MD, PhD	Copenhagen University Hospital, Copenhagen, Denmark
Principal Investigator:	Christian Hassager, MD, DMSc	Copenhagen University Hospital, Copenhagen, Denmark
Principal Investigator:	Jesper Kjaergaard, MD, PhD	Copenhagen University Hospital, Copenhagen, Denmark
Principal Investigator:	Jan Hovdenes, MD, PhD	Oslo University Hospital, Oslo, Norway
Principal Investigator:	Pascal Stammet, MD	Centre Hospitalier du Luxembourg
Principal Investigator:	Yvan Gasche, MD, PhD	Geneva University Hospital, Geneva, Switzerland
Principal Investigator:	Thomas Pellis, MD, PhD	Santa Maria degli Angeli Hospital, Pordenone, Italy
Principal Investigator:	Matt Wise, MD, DPhil	University Hospital of Wales, Cardiff, UK
Principal Investigator:	Anders Åneman, MD, PhD	Liverpool Hospital, Sydney, Australia
Principal Investigator:	Jørn Wetterslev, MD, PhD	Copenhagen Trial Unit, Copenhagen University Hospital, Copenhagen, Denmark
Principal Investigator:	Michael Kuiper, MD, PhD	Leeuwarden Hospital, Leeuwarden, the Netherlands
Principal Investigator:	David Erlinge, MD, PhD	Lund University Hospital, Lund, Sweden

Information Provided By

Helsingborgs Hospital

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top