Organ Donation and Hydrocortisone Treatment (HYDRO)

Kuopio University Hospital

Status: Terminated

Conditions: Brain Death

Treatments: Drug: hydrocortisone; Drug: sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00675272

KUH5070197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

hydrocortisone treatment 50mg iv x4

Treatment:

Drug: hydrocortisone

2

Placebo Comparator group

Description:

Placebo iv every 6 hours

Treatment:

Drug: sodium chloride