Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest

This study has been completed.
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT00411879
First received: December 14, 2006
Last updated: July 23, 2008
Last verified: July 2008
  Purpose

A randomized controlled trial did not show benefit of vasopressin versus epinephrine in inhospital cardiac arrest. Preceding laboratory data suggest that combined vasopressin and epinephrine ensure long-term survival and neurologic recovery. Also, postresuscitation abnormalities mimic severe sepsis. The investigators hypothesized that combined vasopressin and epinephrine during cardiopulmonary resuscitation (CPR), and steroid supplementation during and after (when required) CPR may improve survival in cardiac arrest.


Condition Intervention Phase
Heart Arrest
Drug: Vasopressin, Epinephrine, and Steroids
Drug: Placebo, Epinephrine, Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Single-Center, Placebo-Controlled Study of the Effects of Combined Administration of Vasopressin, Methylprednisolone, and Epinephrine During Cardiopulmonary Resuscitation on Survival After Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • 1) Return of Spontaneous Circulation for > 15 min and 2) Survival to discharge either to home or to a rehabilitation facility. [ Time Frame: 60 days (actual) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sequential Organ Dysfunction Assessment Score during follow-up. Organ failure free days. [ Time Frame: 60 days (actual) ] [ Designated as safety issue: No ]
  • Neurological status during follow-up. [ Time Frame: 60 days (actual) ] [ Designated as safety issue: No ]
  • Cerebral performance during follow-up and at discharge. [ Time Frame: 60 days (actual) ] [ Designated as safety issue: No ]
  • Peri-arrest arterial pressure [ Time Frame: 30 minutes (actual) ] [ Designated as safety issue: No ]
  • Plasma cytokine concentration [ Time Frame: 7 days (actual) ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group
Patients with refractory cardiac arrest (as defined in methods) treated according to the latest guidelines for resuscitation and receiving placebo instead of vasopressin and corticosteroids
Drug: Placebo, Epinephrine, Placebo
Epinephrine is given to both groups according to guidelines for resuscitation 2005. Control group patients receive placebo instead of vasopressin and steroids.
Experimental: Study Group
Patients with refractory cardiac arrest treated with combined vasopressin, epinephrine, and methylprednisolone during resuscitation. Patients receive stress-dose hydrocortisone for postresuscitation shock
Drug: Vasopressin, Epinephrine, and Steroids
During resuscitation, study group patients receive vasopresssin [20 IU IV maximum dose = 100 IU] and methylprednisolone (40 mg IV). Epinephrine is given to both groups according to guidelines for resuscitation 2005. In the study group, postresuscitation shock is treated with stress-dose hydrocortisone.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult in-patients with cardiac arrest requiring epinephrine according to current guidelines.

Exclusion Criteria:

  • Age < 18 years.
  • Documented terminal illness (life expectancy < 6 weeks).
  • Do not resuscitate status.
  • Cardiac arrest before arrival at hospital.
  • Prior enrollment into the study (i.e. second or third inhospital arrest etc.).
  • Corticosteroid treatment before the cardiac arrest.
  • Any inaccurate documentation of CPR data such as medication, number of countershocks etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411879

Locations
Greece
Evaggelismos General Hospital
Athens, Attica, Greece, 106 75
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Spyros D Mentzelopoulos, Lecturer First Department of Intensive Care Medicine, Univerisy of Athens Medical School
Study Chair: Charis Roussos, Professor First Department of Intensive Care Medicine, Univerisy of Athens Medical School
Study Director: Spyros G Zakynthinos, As Professor First Department of Intensive Care Medicine, Univerisy of Athens Medical School
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spyros D. Mentzelopoulos, University of Athens Medical School
ClinicalTrials.gov Identifier: NCT00411879     History of Changes
Other Study ID Numbers: 10531-VMA
Study First Received: December 14, 2006
Last Updated: July 23, 2008
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by University of Athens:
Heart Arrest
Cardiopulmonary Resuscitation
Epinephrine
Vasopressin
Adrenal Cortex Hormones

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Vasopressins
Arginine Vasopressin
Epinephrine
Racepinephrine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Epinephryl borate
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014