NCT00843297

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 efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

February 12, 2009

Last Update Submit

February 1, 2010

Conditions

Cardiac ArrestHypothermia

Keywords

Sudden Cardiac ArrestHypothermiaOutcome, neurologicalCoolgardArcticSun

Outcome Measures

Primary Outcomes (2)

  • Time to reach the target temperature

    Twenty-four hours

  • NSE as a parameter for cerebral damage

    Seventy-two hours

Secondary Outcomes (3)

  • Neurologic outcome

    Six months

  • Survival

    Six months

  • Periprocedural complications

    Seventy-two hours

Study Arms (3)

CG

ACTIVE COMPARATOR

Coolgard: invasive Cooling

Device: Coolgard

AS

ACTIVE COMPARATOR

ArcticSun: Surface-Cooling

Device: ArcticSun

UnCOOL

SHAM COMPARATOR

No Cooling-Therapy due to non-operational cooling-devices

Other: Conventional treatment

Interventions

CoolgardDEVICE

invasive Cooling via femoral ICY-catheter

CG
ArcticSunDEVICE

Noninvasive surface-cooling by saline-cooled thermo-vest

AS
Conventional treatmentOTHER

Intensive care-treatment without cooling

UnCOOL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ROSC after SCA due to VF/VT or PEA/Asystolia
  • GCS 3

You may not qualify if:

  • Non-cardiac SCA
  • Pregnancy
  • Unstable Circulation instead of High-dose Inotropics
  • Life-expectancy reducing concomitant illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig, Heart Center, Cardiology

Leipzig, 04289, Germany

Location

Related Publications (2)

  • Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.

    PMID: 10625721BACKGROUND

  • Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.

    PMID: 11856794BACKGROUND

MeSH Terms

Conditions

Heart ArrestHypothermiaDeath, Sudden, CardiacNeurologic Manifestations

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDeath, SuddenDeathPathologic ProcessesNervous System Diseases

Study Officials

  • Holger Thiele, Associate Professor

    Study Chair

    PRINCIPAL INVESTIGATOR

  • Undine Pittl, MD

    Study Sub-Investigator

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

April 1, 2008

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

February 2, 2010

Record last verified: 2010-01

Locations

DE(1)