Follow up After Survived Therapy With Mild Induced Hypoth... | NCT01083069

Studies
Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)

NCT01083069

Sponsor

University of Leipzig

Status

Unknown status

Last Update Posted

Mar 9, 2010Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Cardiac Arrest
Hypothermia

Interventions

Not provided

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

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Feb 25, 2010

First Submission Date that Met QC Criteria

Mar 8, 2010

First Posted Date

Mar 9, 2010Estimated

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

Mar 8, 2010

Last Update Posted Date

Mar 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.

Detailed Description

Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC).

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COOL		Patients after therapy with mild hypothermia
UnCool		Patients without therapy with mild hypothermia due to non-operational cooling-devices

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurological outcome after 6 month after MIH, Quality of life-survey	Neurological outcome after 6 month after MIH measured by questionnaire.	6 Month

Secondary Outcomes

Measure	Description	Time Frame
Managing daily activities	Managing daily activities after 6 month after tMIH measured with a questionnaire.	6 Month
Surviving after hospitalization	Surviving after hospitalization after MIH

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

survived cardiac arrest
voluntary consent

Exclusion Criteria:

no voluntary consent

Accepts Healthy Volunteers

Yes

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

Patients after restoration of spontaneous circulation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Undine Pittl, MD	Contact	0049-341-8651427		undine.pittl@gmail.com
Holger Thiele, Associate Professor	Contact	0049-341-8651427		thielh@med.uni-leipzig.de

Overall Officials

Name	Affiliation	Role
Holger Thiele, Associate Professor	Study Chair	Principal Investigator
Undine Pittl, MD	Study Sub-invesigator	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig, Heart Center, Cardiology	Recruiting	Leipzig			Germany

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D007035	Hypothermia
D016757	Death, Sudden, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001832	Body Temperature Changes
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided