The Cardiac Effects of Prolonged Hypothermia After Cardiac Arrest

NCT02066753 | Completed

• 1 other identifier: TTH48AG
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

This PhD study is a sub study in a randomized clinical controlled multicenter trial named "TTH48" (ClinicalTrials.gov Identifier: NCT01689077). The TTH48 trial examines prolonged mild therapeutic hypothermia ("MTH") at 32-34°C in 24 versus 48 hours with the primary outcome Cerebral Performance Category after 6 month in comatose out-of-hospital cardiac arrest patients. THE OVERALL AIM OF THIS PhD STUDY IS TO INVESTIGATE THE CARDIAC FUNCTION AND THE HEMODYNAMICS BY BIOCHEMICAL CARDIAC MARKERS, ECHOCARDIOGRAPHY, BY ANALYZING THE USAGE OF INOTROPES/VASOPRESSORS AND BY ANALYZING ECG DATA FOR ARRHYTHMIAS IN THE 24 VERSUS 48 HOURS MTH GROUPS.

Conditions

Cardiac Arrest; Hypothermia

Keywords

Cardiac arrest; Therapeutic Hypothermia; Cardioprotectiveness; Hemodynamics

Outcome Measures

Primary Outcomes (4)

• Area under the curve cTnT

  Allocated sub study 1

  In the intervention period from 24 to 72 hours

• Mitral annular systolic velocity

  Allocated sub study 2

  After 24 hours, 48 hours and 72 hours

• Duration of arrhythmias

  Allocated sub study 3

  From target temperature (32-34°C) has been reached until 72 hours after

• Cumulative vasopressor index

  Allocated sub study 3

  From target temperature (32-34°C) has been reached until 72 hours after

Secondary Outcomes (1)

• Area under the curve NT-proBNP

  In the intervention period from 24 to 72 hours

Study Arms (2)

24 hours mild therapeutic hypothermia

ACTIVE COMPARATOR

The patient will be treated with mild therapeutic hypothermia for 24 hours after reaching the target temperature between 32-34°C.

Procedure: Mild therapeutic hypothermia

48 hours mild therapeutic hypothermia

EXPERIMENTAL

The patient will be treated with mild therapeutic hypothermia for 48 hours after reaching the target temperature between 32-34°C.

Procedure: Mild therapeutic hypothermia

Interventions

Mild therapeutic hypothermia PROCEDURE

Mild therapeutic hypothermia with a target temperature between 32-34°C.

24 hours mild therapeutic hypothermia; 48 hours mild therapeutic hypothermia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resuscitated after cardiac arrest outside hospital with suspected cardiac triggering cause (and stabile circulation for at least 20 minutes after return of spontaneous circulation,
• Glasgow coma score \< 8 and
• Age ≥ 18 years and \< 80 years.

You may not qualify if:

• Cardiac arrest of suspected non-cardiac triggering cause (e.g. trauma, aortic dissection, massive bleeding, hypoxia or accidental hypothermia),
• \>60 minutes from cardiac arrest to ROSC,
• Time from cardiac arrest until start of cooling \>4 hours,
• Terminal illness,
• Coagulopathy (medical anticoagulation treatment including thrombolysis is not a contraindication),
• Unwitnessed arrests with asystolia as presenting rhythm,
• Pregnancy,
• Persistent cardiogenic shock,
• Systolic blood pressure \<80 mmHg despite vasoactive treatment and intra-aortic balloon pump
• CPC 3-4 before the cardiac arrest,
• Suspected/confirmed acute intra cerebral hemorrhage or stroke,
• Acute CABG or other operation in connection with performing CPR,
• Lack of consent from the relatives,
• Lack of consent from the GP and
• Lack of consent from the patient if he/she wakes up and is relevant.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Skejby

Aarhus N, Central Jutland, 8200, Denmark

Location

Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Stavanger University Hospital

Stavanger, 4068, Norway

Location

Related Publications (2)

• Jensen TH, Juhl-Olsen P, Nielsen BRR, Heiberg J, Duez CHV, Jeppesen AN, Frederiksen CA, Kirkegaard H, Grejs AM. Echocardiographic parameters during prolonged targeted temperature Management in out-of-hospital Cardiac Arrest Survivors to predict neurological outcome - a post-hoc analysis of the TTH48 trial. Scand J Trauma Resusc Emerg Med. 2021 Feb 19;29(1):37. doi: 10.1186/s13049-021-00849-7.

  PMID: 33608045 DERIVED

• Grejs AM, Nielsen BRR, Juhl-Olsen P, Gjedsted J, Sloth E, Heiberg J, Frederiksen CA, Jeppesen AN, Duez CHV, Hamre PD, Soreide E, Kirkegaard H. Effect of prolonged targeted temperature management on left ventricular myocardial function after out-of-hospital cardiac arrest - A randomised, controlled trial. Resuscitation. 2017 Jun;115:23-31. doi: 10.1016/j.resuscitation.2017.03.021. Epub 2017 Apr 2.

  PMID: 28377297 DERIVED

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anders Grejs, MD

  Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Skejby, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 19, 2014
• Study Start: February 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

NO (1); DK (1)