Organ Donation and Hydrocortisone Treatment

Not Applicable

Terminated

• Conditions: Brain Death
• Interventions: Drug: hydrocortisone; Drug: sodium chloride

• Registration Number: NCT00675272
• Lead Sponsor: Kuopio University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-08
• Study First Posted: 2008-05-09
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-03
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

all have to be fulfilled

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	hydrocortisone	hydrocortisone treatment 50mg iv x4
2	sodium chloride	Placebo iv every 6 hours

Primary Outcome Measures

Name	Time	Method
dosage and time on norepinephrine treatment	in ICU

Secondary Outcome Measures

Name	Time	Method
Hormone levels and number of organs donated	Hospital treatment

Trial Locations

Locations (2)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland