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

Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01083069

Enrollment

150

Registered

2010-03-09

Start date

2010-01-31

Completion date

2011-06-30

Last updated

2010-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Hypothermia

Keywords

Sudden cardiac arrest, hypothermia, neurological outcome

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* survived cardiac arrest * voluntary consent

Exclusion criteria

* no voluntary consent

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Managing daily activities	6 Month	Managing daily activities after 6 month after tMIH measured with a questionnaire.
Surviving after hospitalization	6 Month	Surviving after hospitalization after MIH
Neurological outcome depending of the beginning of MIH	6 month	Neurological outcome depending of the beginning of MIH
Neurological Outcome in consideration of the practice of the treating instances.	6 month	Neurological outcome in consideration of the practice of the treating instances after restoration of spontanous circulation measured with a questionnaire.

Countries

Germany

Contacts

Primary ContactUndine Pittl, MD

undine.pittl@gmail.com0049-341-8651427

Backup ContactHolger Thiele, Associate Professor

thielh@med.uni-leipzig.de0049-341-8651427

Outcome results