Hypothermia After In-hospital Cardiac Arrest

NCT00457431 | Terminated DMC

• 1 other identifier: HACA in-hospital
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

ILCOR Recommendations "On the basis of the published evidence to date, the Advanced Life Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made the following recommendations in October 2002: Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest" (Circulation. 2003;108:118-121). This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.

Conditions

Cardiac Arrest

Keywords

in-hospital cardiac arrest; resuscitation; mild therapeutic hypothermia

Outcome Measures

Primary Outcomes (1)

• all cause mortality at 6 months

  6 months

Secondary Outcomes (2)

• neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale

  6 months

• in-hospital all cause mortality

  time until discharge or death

Study Arms (2)

Control

NO INTERVENTION

Standard therapy as used in the hospital's ICU

Hypothermia

ACTIVE COMPARATOR

Standard therapy as used in the hospital's ICU plus Hypothermia

Procedure: Mild therapeutic hypothermia

Interventions

Mild therapeutic hypothermia PROCEDURE

Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals

Hypothermia

Eligibility Criteria

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

You may qualify if:

• in-hospital cardiac arrest
• restoration of spontanous circulation
• unconsciousness
• age over 18
• initiation of mild therapeutic hypothermia is possible within 4h after resuscitation

You may not qualify if:

• active bleeding
• suspicion of intra cranial bleeding
• severe infection
• aquired immun deficency
• severe rhythm disorders
• suspicion of cerebral insult
• known severe cognotive deficit before the index event
• pregnancy
• pre existing disease which makes 6 months survival unlikely

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• University of Hamburg-Eppendorf: collaborator
• University of Leipzig: collaborator
• University of Jena: collaborator

Study Sites (1)

Sebastian Wolfrum

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (2)

• Wolfrum S, Roedl K, Hanebutte A, Pfeifer R, Kurowski V, Riessen R, Daubmann A, Braune S, Soffker G, Bibiza-Freiwald E, Wegscheider K, Schunkert H, Thiele H, Kluge S; Hypothermia After In-Hospital Cardiac Arrest Study Group. Temperature Control After In-Hospital Cardiac Arrest: A Randomized Clinical Trial. Circulation. 2022 Nov;146(18):1357-1366. doi: 10.1161/CIRCULATIONAHA.122.060106. Epub 2022 Sep 28.

  PMID: 36168956 DERIVED

• Soar J, Nolan JP. Mild hypothermia for post cardiac arrest syndrome. BMJ. 2007 Sep 8;335(7618):459-60. doi: 10.1136/bmj.39315.519201.BE.

  PMID: 17823147 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sebastian Wolfrum, MD

  University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II

  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: PRINCIPAL INVESTIGATOR
• PI Title: D. Sebastian Wolfrum

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: April 3, 2007
• Primary Completion: November 9, 2014
• Study Completion: March 1, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

DE (1)