HYDRO: Organ Donation and Hydrocortisone Treatment

• Sponsor: Kuopio University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00675272
• Collaborator: Tampere University Hospital (Other)
• Enrollment: 38
• Locations: 2
• Arms: 2
• Duration (Months): 43
• Patients Per Site: 19
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Death	Drug: hydrocortisone; Drug: sodium chloride	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 hydrocortisone treatment 50mg iv x4	Drug: hydrocortisone; hydrocortisone 50mg iv. every 6 hours
Placebo Comparator: 2 Placebo iv every 6 hours	Drug: sodium chloride; sodium chloride every 6 hours iv

Outcome Measures

Primary Outcome Measures

1. dosage and time on norepinephrine treatment [in ICU]

Secondary Outcome Measures

1. Hormone levels and number of organs donated [Hospital treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuopio University Hospital	Kuopio		Finland	70211
2	Tampere University Hospital	Tampere		Finland

Sponsors and Collaborators

• Kuopio University Hospital
• Tampere University Hospital

Investigators

• Study Director: Stepani Bendel, MD, Kuopio University Hospital
• Study Director: Esko Ruokonen, MD, PhD, Kuopio University Hospital
• Study Chair: Jyrki Tenhunen, MD, PhD, Tampere UH
• Principal Investigator: Anna-Maija Antman, MD, Tampere UH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stepani Bendel, MD PhD, Kuopio University Hospital
• ClinicalTrials.gov Identifier: NCT00675272
• Other Study ID Numbers: KUH5070197
• First Posted: May 9, 2008
• Last Update Posted: Apr 6, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Stepani Bendel, MD PhD, Kuopio University Hospital: brain death; subarachnoid hemorrhage; traumatic brain injury; brain injury; intracerebral hemorrhage; organ donation
• Additional relevant MeSH terms: Brain Death; Hydrocortisone

Study Results

No Results Posted as of Apr 6, 2015