Combined Vasopressin, Methylprednisolone, and Epinephrine for Inhospital Cardiac Arrest

NCT00411879 | Completed Phase 2 DMC

• 1 other identifier: 10531-VMA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Arrest

Keywords

Heart Arrest; Cardiopulmonary Resuscitation; Epinephrine; Vasopressin; Adrenal Cortex Hormones

Outcome Measures

Primary Outcomes (1)

• 1) Return of Spontaneous Circulation for > 15 min and 2) Survival to discharge either to home or to a rehabilitation facility.

  60 days (actual)

Secondary Outcomes (5)

• Sequential Organ Dysfunction Assessment Score during follow-up. Organ failure free days.

  60 days (actual)

• Neurological status during follow-up.

  60 days (actual)

• Cerebral performance during follow-up and at discharge.

  60 days (actual)

• Peri-arrest arterial pressure

  30 minutes (actual)

• Plasma cytokine concentration

  7 days (actual)

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Study Group

EXPERIMENTAL

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

Interventions

Vasopressin, Epinephrine, and Steroids DRUG

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.

Study Group

Placebo, Epinephrine, Placebo DRUG

Epinephrine is given to both groups according to guidelines for resuscitation 2005. Control group patients receive placebo instead of vasopressin and steroids.

Control Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Evaggelismos General Hospital

Athens, Attica, 106 75, Greece

Location

Related Publications (4)

• Wenzel V, Krismer AC, Arntz HR, Sitter H, Stadlbauer KH, Lindner KH; European Resuscitation Council Vasopressor during Cardiopulmonary Resuscitation Study Group. A comparison of vasopressin and epinephrine for out-of-hospital cardiopulmonary resuscitation. N Engl J Med. 2004 Jan 8;350(2):105-13. doi: 10.1056/NEJMoa025431.

  PMID: 14711909 BACKGROUND

• Stiell IG, Hebert PC, Wells GA, Vandemheen KL, Tang AS, Higginson LA, Dreyer JF, Clement C, Battram E, Watpool I, Mason S, Klassen T, Weitzman BN. Vasopressin versus epinephrine for inhospital cardiac arrest: a randomised controlled trial. Lancet. 2001 Jul 14;358(9276):105-9. doi: 10.1016/S0140-6736(01)05328-4.

  PMID: 11463411 BACKGROUND

• Holmberg MJ, Granfeldt A, Mentzelopoulos SD, Andersen LW. Vasopressin and glucocorticoids for in-hospital cardiac arrest: A systematic review and meta-analysis of individual participant data. Resuscitation. 2022 Feb;171:48-56. doi: 10.1016/j.resuscitation.2021.12.030. Epub 2022 Jan 3.

  PMID: 34990764 DERIVED

• Mentzelopoulos SD, Zakynthinos SG, Tzoufi M, Katsios N, Papastylianou A, Gkisioti S, Stathopoulos A, Kollintza A, Stamataki E, Roussos C. Vasopressin, epinephrine, and corticosteroids for in-hospital cardiac arrest. Arch Intern Med. 2009 Jan 12;169(1):15-24. doi: 10.1001/archinternmed.2008.509.

  PMID: 19139319 DERIVED

MeSH Terms

Conditions

Heart Arrest; Diabetes Insipidus

Interventions

Vasopressins; Epinephrine; Steroids

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Spyros D Mentzelopoulos, Lecturer

  First Department of Intensive Care Medicine, Univerisy of Athens Medical School

  PRINCIPAL INVESTIGATOR

• Charis Roussos, Professor

  First Department of Intensive Care Medicine, Univerisy of Athens Medical School

  STUDY CHAIR

• Spyros G Zakynthinos, As Professor

  First Department of Intensive Care Medicine, Univerisy of Athens Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Intensive Care Medicine

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 15, 2006
• Study Start: June 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

GR (1)