MedTrace Logo

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

NCT00965016 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2009-08-25

No results posted yet for this study

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. in cardiac arrest that necessitated external or open-chest cardiac massage and a large amount of epinephrine (\>5 mg) during CPR.
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.

Expected result:

We will prove ECPR with hypothermia is a perfect strategy. And within three groups of the patients, ECMO +induced hypothermia will be the most optimal choice.

Conditions

  • Out-of-Hospital Cardiac Arrest

Interventions

PROCEDURE

hypothermia

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

Sponsors & Collaborators

  • Min-Sheng General Hospital

    lead OTHER

Principal Investigators

  • Shaojung Li, physician · Director, department of cardiovascular surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00965016 on ClinicalTrials.gov