Organ Donation and Hydrocortisone Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-12-31

Brief Summary

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Brain death patients who are selected for organ donation very often suffer from haemodynamic instability. To treat this, high amounts of vasoactive drugs(norepinephrine) may be needed to raise blood pressure. However,norepinephrine may have negative influence on several organs causing reduced blood flow ischemia. Our hypothesis is that hydrocortisone treatment may reduce the amount of vasoactive drugs needed to keep the blood pressure stable in patients selected for organ donation.

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Detailed Description

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When patients are treated in the ICU only as possible organ donators they will be assessed for eligibility for the study. Iv hydrocortisone or placebo will be administered every 6 hours. Several hormonal samples will be collected.

Conditions

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Brain Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

hydrocortisone treatment 50mg iv x4

Group Type ACTIVE_COMPARATOR

hydrocortisone

Intervention Type DRUG

hydrocortisone 50mg iv. every 6 hours

2

Placebo iv every 6 hours

Group Type PLACEBO_COMPARATOR

sodium chloride

Intervention Type DRUG

sodium chloride every 6 hours iv

Interventions

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hydrocortisone

hydrocortisone 50mg iv. every 6 hours

Intervention Type DRUG

sodium chloride

sodium chloride every 6 hours iv

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* severe brain injury or subarachnoid hemorrhage which progrediates to brain death and patients are treated only as candidates for organ donation in the ICU
* no other reasons for treatment than organ donation
* informed consent from official representative

Exclusion Criteria

* age under 18
* pregnancy
* corticoid treatment before study entry
* adrenal insufficiency
* hypophyseal insufficiency
* treatment with etomidate one week before study entry
* participating in an other study
* no informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No