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Completed

NCT Number: NCT01689077

Time-differentiated Therapeutic Hypothermia

The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Intensive Care, Erasme Hospital, Brussels, Belgium

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About this study

Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However, in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is therefore relevant to investigate the influence of the treatment time on the cerebral outcome in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score measured 6 month after the treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Out of hospital cardiac arrest of suspected cardiac origin
  • Return of spontaneous circulation (ROSC)
  • Glasgow Coma Score < 8
  • Estimated time interval from cardiac arrest to ROSC ≤ 60 min

Exclusion criteria

  • OOH-CA of suspected origin other than cardiac
  • In hospital Cardiac arrest
  • Terminal disease
  • Coagulation disorders
  • Unwitnessed asystolia
  • Time from cardiac arrest to start of hypothermia treatment > 240 min
  • GCS ≥ 8
  • Pregnancy
  • Persistent cardiogenic shock (Systolic blood pressure < 80 mmHg despite inotropic treatment and aortic balloon pump).
  • CPC 3-4 before cardiac arrest
  • Acute intra cerebral bleeding
  • Acute stroke
  • Acute coronary artery bypass grafting

Treatment and study plan

Therapeutic hypothermia

Other

Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours

Primary outcomes

  1. CPC

    Time frame: 6 month

    CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA.

Secondary outcomes

  1. Adverse events

    Time frame: 10 days

    Adverse events are registered during the treatment and until discharge from primary hospital unit

  2. CPC at discharge

    Time frame: 3 month

    CPC at discharge from primary hospital unit and after 28 days plus after 3 month

  3. Mortality

    Time frame: 6 month

    CPC 5 at 6 month

Other outcomes

  1. GCS

    Time frame: 28 days

    Glasgow Coma Score at day 4 and at discharge from primary hospital unit

  2. GCS progression

    Time frame: 25 weeks

    Glasgow Coma Score throughout the observation period

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.

Acronym: TTH48

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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