Target Temperature Management After Cardiac Arrest

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.

Conditions

• Out-of-hospital Cardiac Arrest

Interventions

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

Sponsors & Collaborators

• Scandinavian Critical Care Trials Group

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Lund University

  collaborator OTHER

• The George Institute for Global Health, Australia

  collaborator OTHER

• Niklas Nielsen

  lead OTHER

Principal Investigators

• Niklas Nielsen, MD, PhD · Helsingborgs lasarett, Region Skåne, Sweden

• Janneke Horn, MD, PhD · Academisch Medisch Centrum, Amsterdam, the Netherlands

• Hans Friberg, MD, PhD · Lund University Hospital, Lund, Sweden

• Tobias Cronberg, MD, PhD · Lund University Hospital, Lund, Sweden

• Michael Wanscher, MD, PhD · Copenhagen University Hospital, Copenhagen, Denmark

• Christian Hassager, MD, DMSc · Copenhagen University Hospital, Copenhagen, Denmark

• Jesper Kjaergaard, MD, PhD · Copenhagen University Hospital, Copenhagen, Denmark

• Jan Hovdenes, MD, PhD · Oslo University Hospital, Oslo, Norway

• Pascal Stammet, MD · Centre Hospitalier du Luxembourg

• Yvan Gasche, MD, PhD · Geneva University Hospital, Geneva, Switzerland

• Thomas Pellis, MD, PhD · Santa Maria degli Angeli Hospital, Pordenone, Italy

• Matt Wise, MD, DPhil · University Hospital of Wales, Cardiff, UK

• Anders Åneman, MD, PhD · Liverpool Hospital, Sydney, Australia

• Jørn Wetterslev, MD, PhD · Copenhagen Trial Unit, Copenhagen University Hospital, Copenhagen, Denmark

• Michael Kuiper, MD, PhD · Leeuwarden Hospital, Leeuwarden, the Netherlands

• David Erlinge, MD, PhD · Lund University Hospital, Lund, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-30

Primary Completion

2013-07-31

Completion

2013-07-31

Countries

• Australia
• Czechia
• Denmark
• Italy
• Luxembourg
• Netherlands
• Norway
• Sweden
• Switzerland
• United Kingdom

Study Locations