Organ Donation and Hydrocortisone Treatment

Brain Death Clinical Trial

— HYDRO  

Official title:

Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00675272
• Other study ID #: KUH5070197
• Status: Terminated
• Phase: N/A
• First received: May 7, 2008
• Last updated: April 3, 2015
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2015
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Death

Intervention

Drug:
• hydrocortisone
hydrocortisone 50mg iv. every 6 hours
• sodium chloride
sodium chloride every 6 hours iv

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dosage and time on norepinephrine treatment		in ICU	No
Secondary	Hormone levels and number of organs donated		Hospital treatment	No