Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest

Summary

ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.

Conditions

• Out-of-hospital Cardiac Arrest

Interventions

PROCEDURE

Targeted temperature management to 33°C

Rapid cooling to below 33°C, followed by temperature control at 33°C for up to 28h.

PROCEDURE

Standard care with early treatment of fever

Normothermia and standard care - use of a device for temperature control if temperature is greater than or equal to 37.8°C

Sponsors & Collaborators

• Lund University

  collaborator OTHER

• Region Skåne - Skånevård SUND

  collaborator UNKNOWN

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Clinical Trials Sweden, Forum South

  collaborator UNKNOWN

• Integrated Biobank of Luxembourg

  collaborator OTHER

• Helsingborgs Hospital

  lead OTHER

Principal Investigators

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

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

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

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

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

• Clifton W Callaway, MD, PhD · University of Pittsburgh, Pittsburgh, USA

• Christian Storm, MD, PhD · Charité-University Medicine (Berlin, Germany)

• Alain Cariou, MD, PhD · Université Paris Descartes, France

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

• Christian Rylander, MD, PhD · Sahlgrenska University Hospital

• Josef Dankiewicz, MD, PhD · Skåne University Hospital Lund

• Mauro Oddo, MD, PhD · Université de Lausanne, Lausanne, Switzerland

• Manoj Saxena, MD, PhD · The George Institute for Global Health (Sydney, Australia)

• Per Nordberg, MD, PhD · Södersjukhuset, Stockholm

• Fabio Taccone, MD, PhD · Hopital Erasme, Brussles, Belgium

• Paolo Pelosi, MD, PhD · San Martino University Hospital, Genoa

• Michael Ioannidis, MD, PhD · Innsbruck University Hospital

• Jan Belholavek, MD, PhD · Prague University Hospital

• Paul Young, MD · Wellington Regional Hospital

• Hans Kirkegaard, MD,PhD · Aarhus University Hospital

• Alistair Nichol, MD, PhD · Department of Anaesthesia and Intensive Care Medicine, St Vincent's University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-18

Primary Completion

2022-06-30

Completion

2022-12-31

Countries

• United States
• Australia
• Austria
• Belgium
• Czechia
• Denmark
• France
• Germany
• Italy
• New Zealand
• Norway
• Sweden
• Switzerland
• United Kingdom

Study Locations