Dantrolene for Treatment of Hyperthermia in Subarachnoidal Hemorrhage (SAH)

NCT00796900 | Terminated Phase 2

• 1 other identifier: EK 197/2004
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Dantrolene is used to prevent hyperthermia in intensive care patients suffering from subarachnoidal hemorrhage.

Conditions

Hyperthermia

Keywords

Hyperthermia; subarachnoidal hemorrhage; placebo controlled; double blinded; Dantrolene

Outcome Measures

Primary Outcomes (1)

• Magnitude and Duration of Hyperthermia

  8 hours, every 10 minutes

Study Arms (2)

Dantrolene

EXPERIMENTAL

Drug: Dantrolene

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dantrolene DRUG

Patients who satisfy the inclusion/exclusion criteria of the study and who are enrolled in this study will be randomized with computer-generated grouping to either one of two groups. One group of subjects will be given dantrolene for the first episode of fever. The other group will be given placebo. Dantrolene is supplied in 70-ml vials containing 20 mg dantrolene. Dantrolene will be given in the following dose: 5 mg/kg BW given intravenously over 30 minutes. As placebo NaCl 0,9% will be used.

Dantrolene

Placebo DRUG

Patients who satisfy the inclusion/exclusion criteria of the study and who are enrolled in this study will be randomized with computer-generated grouping to either one of two groups. One group of subjects will be given dantrolene for the first episode of fever. The other group will be given placebo. Dantrolene is supplied in 70-ml vials containing 20 mg dantrolene. Dantrolene will be given in the following dose: 5 mg/kg BW given intravenously over 30 minutes. As placebo NaCl 0,9% will be used.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• neurosurgical patients after subarachnoidal hemorrhage
• breathing spontaneously or being ventilator dependant
• sustained fever (≥38ºC for more than an hour) without an identifiable infectious cause.

You may not qualify if:

• infection
• pregnancy
• arrhythmia
• muscular dystrophia
• acute liver disease

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hyperthermia

Interventions

Dantrolene

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrea Holzer, MD

  Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 12, 2011

Record last verified: 2009-09

Locations

AU (1)