Hypothermia After In-hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

— HACAinhospital  

Official title:

Hypothermia After In-hospital Cardiac Arrest

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00457431
• Other study ID #: HACA in-hospital
• Status: Terminated
• Phase: N/A
• Start date: April 3, 2007
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2021
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized controlled multicenter trial. Patients after in-hospital cardiac arrest are randomized either to standard therapy or to standard therapy in addition to mild therapeutic hypothermia. Mild therapeutic hypothermia is performed for 24 hours with a target temperature of 32-34°C. Inclusion criteria are: Adult patients which have been resuscitated after cardiac arrest in-hospital and who remain unconscious after restoration of spontanous circulation. Exclusion criteria are: severe cardiogenic shock, severe rhythm disorders, major surgery within the last 10 days, planned surgery within the next 24 hours afer resuscitation, active bleeding, suspicion od intracranial bleeding, severe infection, such as pneumonia or sepsis, a severe neurological deficit before cardiac arrest, an aquired immun deficency, pregnacy. The primary endpoint is mortality for all causes after six months. Secondary endpoints are neurological outcome after six months measured by the Glasgow-Pittsburgh Cerebral Performance scale, and in-hospital-mortality.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 249
• Est. completion date: March 1, 2021
• Est. primary completion date: November 9, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• in-hospital cardiac arrest

• restoration of spontanous circulation

• unconsciousness

• age over 18

• initiation of mild therapeutic hypothermia is possible within 4h after resuscitation

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Intervention

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

Locations

Country	Name	City	State
Germany	Sebastian Wolfrum	Lübeck	Schleswig-Holstein

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	University of Hamburg-Eppendorf, University of Jena, University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality at 6 months		6 months
Secondary	neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale		6 months
Secondary	in-hospital all cause mortality		time until discharge or death