Time-differentiated target temperature management after out-of-hospital cardiac arrest: a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial

Kirkegaard, Hans; Rasmussen, Bodil S; de Haas, Inge; Nielsen, Jørgen Feldbæk; Ilkjær, Susanne; Kaltoft, Anne; Jeppesen, Anni Nørregaard; Grejs, Anders; Duez, Christophe Henri Valdemar; Larsen, Alf Inge; Pettilä, Ville Yrjö Olavi; Toome, Valdo; Arus, Urmet; Taccone, Fabio Silvio; Storm, Christian; Skrifvars, Markus B; Søreide, Eldar (2016). Time-differentiated target temperature management after out-of-hospital cardiac arrest: a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial. Trials, 17(1), p. 228. BioMed Central 10.1186/s13063-016-1338-9

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BACKGROUND The application of therapeutic hypothermia (TH) for 12 to 24 hours following out-of-hospital cardiac arrest (OHCA) has been associated with decreased mortality and improved neurological function. However, the optimal duration of cooling is not known. We aimed to investigate whether targeted temperature management (TTM) at 33 ± 1 °C for 48 hours compared to 24 hours results in a better long-term neurological outcome. METHODS The TTH48 trial is an investigator-initiated pragmatic international trial in which patients resuscitated from OHCA are randomised to TTM at 33 ± 1 °C for either 24 or 48 hours. Inclusion criteria are: age older than 17 and below 80 years; presumed cardiac origin of arrest; and Glasgow Coma Score (GCS) <8, on admission. The primary outcome is neurological outcome at 6 months using the Cerebral Performance Category score (CPC) by an assessor blinded to treatment allocation and dichotomised to good (CPC 1-2) or poor (CPC 3-5) outcome. Secondary outcomes are: 6-month mortality, incidence of infection, bleeding and organ failure and CPC at hospital discharge, at day 28 and at day 90 following OHCA. Assuming that 50 % of the patients treated for 24 hours will have a poor outcome at 6 months, a study including 350 patients (175/arm) will have 80 % power (with a significance level of 5 %) to detect an absolute 15 % difference in primary outcome between treatment groups. A safety interim analysis was performed after the inclusion of 175 patients. DISCUSSION This is the first randomised trial to investigate the effect of the duration of TTM at 33 ± 1 °C in adult OHCA patients. We anticipate that the results of this trial will add significant knowledge regarding the management of cooling procedures in OHCA patients. TRIAL REGISTRATION NCT01689077.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Pettilä, Ville Yrjö Olavi

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1745-6215

Publisher:

BioMed Central

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

02 Aug 2016 11:41

Last Modified:

02 Aug 2016 11:41

Publisher DOI:

10.1186/s13063-016-1338-9

PubMed ID:

27142588

Uncontrolled Keywords:

Mild therapeutic hypothermia; Out-of-hospital cardiac arrest; Prolonged target temperature management; Target temperature management

BORIS DOI:

10.7892/boris.84808

URI:

https://boris.unibe.ch/id/eprint/84808

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