Brain DeathHYDRONCT00675272
Organ Donation and Hydrocortisone Treatment
A study testing hydrocortisone and sodium chloride in people with Brain Death, run by Kuopio University Hospital at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death
- What is being tested?
- hydrocortisone and sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesFinland
- Study dates
- May 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Finland2 sites
Kuopio University Hospital
Kuopio, 70211
Tampere University Hospital
Tampere
About this study
Official title: Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment
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.
Read the 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.
- Conditions
- Brain Death
- Being tested
- hydrocortisone, sodium chloride
- Keywords
- brain death, subarachnoid hemorrhage, traumatic brain injury, brain injury, intracerebral hemorrhage, organ donation
- Medical subject headings
- Brain Death, Subarachnoid Hemorrhage, Brain Injuries, Traumatic, Brain Injuries, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
hydrocortisone 50mg iv. every 6 hours
sodium chlorideDrug
sodium chloride every 6 hours iv
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | hydrocortisone treatment 50mg iv x4 Receives: Drug: hydrocortisone |
| 2 | Placebo comparator | Placebo iv every 6 hours Receives: Drug: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosage and time on norepinephrine treatment
Measured: in ICU
Secondary outcomes (1)
Hormone levels and number of organs donated
Measured: Hospital treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2011
- Study completionDec 2011
Why it stopped: Routine use of corticoids became standard therapy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Stepani Bendel, Kuopio University Hospital
- Investigators
- Stepani Bendel, MD, Study director, Kuopio University HospitalEsko Ruokonen, MD, PhD, Study director, Kuopio University HospitalJyrki Tenhunen, MD, PhD, Study chair, Tampere UHAnna-Maija Antman, MD, Principal investigator, Tampere UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675272
- Sponsor's protocol ID
- KUH5070197
- Acronym
- HYDRO
- Status last verified
- Apr 2015
- First submitted
- 7 May 2008
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment
- ClinicalTrials.gov ID
- NCT00675272
- Acronym / sponsor ID
- HYDRO / KUH5070197
- Conditions
- Brain Death
- Keywords
- brain death, subarachnoid hemorrhage, traumatic brain injury, brain injury, intracerebral hemorrhage, organ donation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Routine use of corticoids became standard therapy
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- May 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: hydrocortisonehydrocortisone treatment 50mg iv x4 |
| 2 | Placebo comparator | Drug: sodium chloridePlacebo iv every 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- age under 18
- pregnancy
- corticoid treatment before study entry
- adrenal insufficiency
- hypophyseal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocortisonehydrocortisone 50mg iv. every 6 hours | Drug | 1 |
| sodium chloridesodium chloride every 6 hours iv | Drug | 2 |
Primary outcome
dosage and time on norepinephrine treatment
Time frame: in ICU
1 secondary outcome
Hormone levels and number of organs donated
Time frame: Hospital treatment
Results and safety
The study was stopped early (reason given: Routine use of corticoids became standard therapy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stepani Bendel, MD study director
Kuopio University Hospital
Esko Ruokonen, MD, PhD study director
Kuopio University Hospital
Jyrki Tenhunen, MD, PhD study chair
Tampere UH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrocortisone and sodium chloride in people with Brain Death, run by Kuopio University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Routine use of corticoids became standard therapy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dosage and time on norepinephrine treatment (time frame: in ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.