Therapeutic Hypothermia With Propofol in Survival and Neurological Prognoses After Cardiac Arrest

March 26, 2016 updated by: Yen-Wen Wu, Far Eastern Memorial Hospital

Combining Propofol With Therapeutic Hypothermia for Improving Survival and Neurological Prognoses in Patients Resuscitated From Cardiac Arrest

Therapeutic hypothermia has been proven to significantly improve the survival and neurological prognoses in patients resuscitated from cardiac arrest. Propofol has been reported to exhibit potentials in mitigating ischemia-reperfusion injury via the antioxidative, anti-inflammatory and neuroprotective mechanisms. This study is to investigate the potentials of propofol in further improving the survival and neurological prognoses in this era of therapeutic hypothermia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cardiac arrest and cardiopulmonary resuscitation (CPR) is a specific model of global ischemia/reperfusion (I/R) injury. Among all organ systems, brain is least tolerable to ischemic insult and I/R injury, which accounts for the usually poor survival and neurological outcomes in these patients even with initial success in resuscitation. Therapeutic hypothermia (TH) has been proven to significantly improve the survival and neurological prognoses in patients resuscitated from cardiac arrest. It has been recommended as a standard therapy in the post-resuscitation care since 2002. In the past few years, NTUH and FEMH have been actively promoted the application of TH in the post-resuscitation care, and both have achieved important progress. Based on these, the investigators seek to further improve the survival and neurological outcomes in this group of patients. Among the therapies with potential additive or synergistic protective mechanisms, propofol has been extensively studied, and shown to exhibit great potentials in mitigating ischemia-reperfusion injury via the antioxidative, anti-inflammatory and neuroprotective mechanisms. As sedatives are basic requirement during TH according to technical and ethical concerns, the combination of propofol and TH is not only justified but highly anticipated. The investigators therefore seek to investigate the potentials of propofol in further improving the survival and neurological prognoses in this era of therapeutic hypothermia.

Methods: This .is a prospective, single-blinded randomized clinical trial. The inclusion criteria include: (1) non-traumatic cardiac arrest (2) no regain of consciousness after return of spontaneous circulation (ROSC) (3) age >=20 years old and <= 90 years old. The exclusion criteria include (1) age < 20 y/o or > 90 y/o (2) pregnancy (3) traumatic cardiac arrest (4) fail to achieve ROSC (5) conscious recovery after ROSC (6) contraindications for TH, such as massive bleeding, infections, etc (7) terminal diseases (8) conscious disturbance before cardiac arrest (9) fail to obtain informed consent (10) families refuse to undergo clinical trial. The study will be divided to two groups: (1) Lorazepam group: lorazepam infusion at a rate of 0.5 mg/kg/hr during TH. (2) Propofol group: propofol infusion at a rate of 3 mg/kg/hr during TH. The primary endpoints will be (1) survival (2) neurological outcomes as indicated by cerebral performance category (CPC) scale. The secondary endpoints include (1) 99mTc ECD scan (perfusion and viability), (2) clinical and EEG evidences of seizure. The blood pressure and heart rate will continuously monitored during TH and propofol/lorazepam infusion.

Expected Results: (1) Test if propofol further improves the survival and neurological outcomes in post-CPR patients undergoing TH (2) Test if propofol further improves cerebral perfusion and neuron viability in post-CPR patients undergoing TH (3) Test if propofol reduces the incidence and severity of seizures post-CPR, (4) Test if propofol significantly influence hemodynamics when combined with TH Clinical Implications: Propofol is a clinically available sedative agent. If this trial demonstrates that propofol further improves the survival and neurological outcomes in post-resuscitation patients undergoing TH, it would become an important evidence justifying implementation in clinical practice

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 220
        • Recruiting
        • Far Eastern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Yen-Wen Wu, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. non-traumatic cardiac arrest
  2. no regain of consciousness after return of spontaneous circulation (ROSC)
  3. age >=20 years old and <= 90 years old.

Exclusion criteria:

  1. age < 20 y/o or > 90 y/o
  2. pregnancy
  3. traumatic cardiac arrest
  4. fail to achieve ROSC
  5. conscious recovery after ROSC
  6. contraindications for TH, such as massive bleeding, infections, etc
  7. terminal diseases
  8. conscious disturbance before cardiac arrest
  9. fail to obtain informed consent
  10. families refuse to undergo clinical trial
  11. allergy to propofol or lorazepam.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol
propofol infusion at a rate of 3 mg/kg/hr during TH.
Drug: Propofol
Propofol use during therapeutic hypothermia
Other Names:
  • P
Active Comparator: Lorazepam
lorazepam infusion at a rate of 0.5 mg/kg/hr during TH.
Drug: Lorazepam
Lorazepam use during therapeutic hypothermia
Other Names:
  • L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurologic statue at discharge
Time Frame: at dicharge
Glasgow score, cerebral performance category scale
at dicharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain SPECT The standard 99mTc-ethylene L-cysteinate dimer [ECD] will be done on day 5-14 post-resuscitation. The perfusion will be assessed, and the viability of the cerebral tissue will be interpreted using SPECT, by 2 experienced nuclear m
Time Frame: day 5-14 post-resuscitation
Regional Scores of Tc-99m ECD Brain SPECT
day 5-14 post-resuscitation
From ROSC to recovery of consciousness
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Recovery of consciousness: being able to follow orders. participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Survival to discharge
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 26, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102060-F_102-FTN12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Not share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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