Organ Donation and Hydrocortisone Treatment

Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment

Sponsors

Lead Sponsor: Kuopio University Hospital

Collaborator: Tampere University Hospital

Source 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.

Overall Status Terminated
Start Date May 2008
Completion Date December 2011
Primary Completion Date August 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
dosage and time on norepinephrine treatment in ICU
Secondary Outcome
Measure Time Frame
Hormone levels and number of organs donated Hospital treatment
Enrollment 38
Condition
Intervention

Intervention Type: Drug

Intervention Name: hydrocortisone

Description: hydrocortisone 50mg iv. every 6 hours

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: sodium chloride

Description: sodium chloride every 6 hours iv

Arm Group Label: 2

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility:
Kuopio University Hospital | Kuopio, 70211, Finland
Tampere University Hospital | Tampere, Finland
Location Countries

Finland

Verification Date

April 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kuopio University Hospital

Investigator Full Name: Stepani Bendel

Investigator Title: MD PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Active Comparator

Description: hydrocortisone treatment 50mg iv x4

Label: 2

Type: Placebo Comparator

Description: Placebo iv every 6 hours

Acronym HYDRO
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov