Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation.

NCT00965016 | Unknown Early Phase 1

• 1 other identifier: MSEIRB0980106
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Background： Cardiopulmonary resuscitation (CPR) with closed-chest cardiac massage has been shown that survival to discharge rate is poor. Attempt to increase success, some aggressive methods such as extracorporeal membrane oxygenation (ECMO) has been used (also known as extracorporeal cardiopulmonary resuscitation, ECPR). Otherwise, anoxic brain injury is another issue after CPR. In recent years, some randomized prospective controlled trials of induced hypothermia (IH) to 33℃ for 12 to 24 hours has been demonstrated to significantly improve outcome in cardiac arrest patients. Because ECMO also could provide hypothermia management, we plan this study to evaluate the cerebroprotective effect of ECPR with induced hypothermia. We will try to analyze risk factors influencing patient survival and weaning from ECPR and the optimal management for this ominous prognosis group. Method: The patients were recruited into the ECPR group only if they:

1. 1.in cardiac arrest that necessitated external or open-chest cardiac massage and a large amount of epinephrine (\>5 mg) during CPR.
2. 2.Could not be returned to spontaneous circulation within 10 to 20 min. After ECPR, the body temperature was started to be cooled down. Within 3 hours, the patients have been well studied to search for potential reason of CPR. If the patients have no heart problem or only intervention needed, they can be grouped into 1. Group 2 is the group, which some further operation must be delivered. Group 3 is the group who cannot afford to receive hypothermia (The physician in charge don't agree the trial.) In ECMO-supported patients, two resulting comparisons were of concern: 1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death. We attempted to identify the risk factors that affected weaning and survival, and we analyzed the effect of ECPR with hypothermia on survival.

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

Extracorporeal membrane oxygenation，induced hypothermia

Outcome Measures

Primary Outcomes (1)

• 1) ECMO weaning versus nonweaning and 2) survival-to-discharge versus in-hospital death.

  20091231

Secondary Outcomes (1)

• Brain injury

  20091231

Study Arms (3)

No Hypothermia, No intervention, ECMO

SHAM COMPARATOR

No hypothermia used during ECPR

Procedure: hypothermia

Hypothermia, intervention, ECMO

ACTIVE COMPARATOR

Hypothermia + intervention

Procedure: hypothermia

Hypothermia, no intervention, ECMO

ACTIVE COMPARATOR

Hypothermia without intervention after ECMO

Procedure: hypothermia

Interventions

hypothermia PROCEDURE

Core temperature --\> 34.9℃ within 30 min --\> 33.5℃ within 120min --\> 33℃for 24 H Decrease temperature in 0.9℃/hour

Also known as: ECPR

Hypothermia, intervention, ECMO; Hypothermia, no intervention, ECMO; No Hypothermia, No intervention, ECMO

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. in cardiac arrest that necessitated external or open-chest cardiac massage and a large amount of epinephrine (\>5 mg) during CPR.
• \. Could not be returned to spontaneous circulation within 10 to 20 min

You may not qualify if:

• contraindicated to ECMO use

Sponsors & Collaborators

• Min-Sheng General Hospital: lead

Study Sites (1)

Min-sheng General Hospital

Taoyuan District, 330, Taiwan

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Shaojung Li, physician

  Director, department of cardiovascular surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaojung Li, physician

CONTACT

886-3-3179599; shaojung@ms24.hinet.net

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2009
• First Posted: August 25, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

TW (1)