Hypothermia After In-hospital Cardiac Arrest | NCT00457431

Studies
Hypothermia After In-hospital Cardiac Arrest

NCT00457431

Sponsor

University Hospital Schleswig-Holstein

Status

Terminated

Last Update Posted

Jun 22, 2021Actual

Enrollment

249Actual

Phase

Not Applicable

Conditions

Cardiac Arrest

Interventions

Mild therapeutic hypothermia

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

interim analysis with stopping for futility

Expanded Access Info

Start Date

Apr 3, 2007Actual

Primary Completion Date

Nov 9, 2014Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 4, 2007

First Posted Date

Apr 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2021

Last Update Posted Date

Jun 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sebastian Wolfrum, D. Sebastian Wolfrum, University Hospital Schleswig-HolsteinPrincipal Investigator

Lead Sponsor

University Hospital Schleswig-HolsteinOTHER

Collaborators

Name	Class
University of Hamburg-Eppendorf	OTHER
University of Leipzig	OTHER
University of Jena	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

249Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Mild therapeutic hypothermia	Procedure	Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals	Hypothermia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause mortality at 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastian Wolfrum, MD	University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sebastian Wolfrum		Lübeck	Schleswig-Holstein	23538	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36168956	Derived	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.
17823147

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases