Organ Donation and Hydrocortisone Treatment

Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00675272

Acronym

HYDRO

Enrollment

Registered

2008-05-09

Start date

2008-05-31

Completion date

2011-12-31

Last updated

2015-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death

Keywords

brain death, subarachnoid hemorrhage, traumatic brain injury, brain injury, intracerebral hemorrhage, organ donation

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.

Interventions

DRUGhydrocortisone

hydrocortisone 50mg iv. every 6 hours

DRUGsodium chloride

sodium chloride every 6 hours iv

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
dosage and time on norepinephrine treatment	in ICU

Secondary

Measure	Time frame
Hormone levels and number of organs donated	Hospital treatment

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026