Target Temperature Management After Cardiac Arrest (TTM)
This study has been completed.
Sponsor:
Niklas Nielsen
Collaborators:
Scandinavian Critical Care Trials Group
Copenhagen Trial Unit, Center for Clinical Intervention Research
Lund University
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Niklas Nielsen, Helsingborgs Hospital
ClinicalTrials.gov Identifier:
NCT01020916
First received: November 25, 2009
Last updated: July 8, 2013
Last verified: July 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Out-of-hospital Cardiac Arrest |
Procedure: Target temperature 36°C Procedure: Target Temperature 33°C |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Target Temperature Management 33°C Versus 36°C After Out-of-hospital Cardiac Arrest, a Randomised, Parallel Groups, Assessor Blinded Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Helsingborgs Hospital:
Primary Outcome Measures:
- All-cause mortality [ Time Frame: Maximum follow-up with a minimum of 180 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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
Other Outcome Measures:
- 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
| Estimated Enrollment: | 950 |
| Study Start Date: | November 2010 |
| Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Target Temperature 33°C |
Procedure: Target Temperature 33°C
In hospital target temperature management to achieve a core body temperature of 33°C for 24 hours
|
| Active Comparator: Target Temperature 36°C |
Procedure: Target temperature 36°C
In hospital target temperature management to achieve a core body temperature of 36°C for 24 hours
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01020916
Show 33 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020916
Show 33 Study Locations
Sponsors and Collaborators
Niklas Nielsen
Scandinavian Critical Care Trials Group
Copenhagen Trial Unit, Center for Clinical Intervention Research
Lund University
The George Institute for Global Health, Australia
Investigators
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Niklas Nielsen, Consultant in Anesthesia and Intensive Care, MD, PhD, Helsingborgs Hospital |
| ClinicalTrials.gov Identifier: | NCT01020916 History of Changes |
| Other Study ID Numbers: | TTM-1 |
| Study First Received: | November 25, 2009 |
| Last Updated: | July 8, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board Sweden: Region Skåne |
Keywords provided by Helsingborgs Hospital:
|
Induced hypothermia Mild induced hypothermia Therapeutic hypothermia Cardiac arrest |
Out-of-hospital cardiac arrest Mortality Neurological function Randomised clinical trial |
Additional relevant MeSH terms:
|
Heart Arrest Out-of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Diseases |
ClinicalTrials.gov processed this record on March 03, 2015