NCT00675272

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

May 7, 2008

Last Update Submit

April 3, 2015

Conditions

Brain Death

Keywords

brain deathsubarachnoid hemorrhagetraumatic brain injurybrain injuryintracerebral hemorrhageorgan donation

Outcome Measures

Primary Outcomes (1)

  • dosage and time on norepinephrine treatment

    in ICU

Secondary Outcomes (1)

  • Hormone levels and number of organs donated

    Hospital treatment

Study Arms (2)

1

ACTIVE COMPARATOR

hydrocortisone treatment 50mg iv x4

Drug: hydrocortisone

2

PLACEBO COMPARATOR

Placebo iv every 6 hours

Drug: sodium chloride

Interventions

hydrocortisoneDRUG

hydrocortisone 50mg iv. every 6 hours

1
sodium chlorideDRUG

sodium chloride every 6 hours iv

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Brain DeathSubarachnoid HemorrhageBrain Injuries, TraumaticBrain InjuriesCerebral Hemorrhage

Interventions

HydrocortisoneSodium Chloride

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhageCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Stepani Bendel, MD

    Kuopio University Hospital

    STUDY DIRECTOR

  • Esko Ruokonen, MD, PhD

    Kuopio University Hospital

    STUDY DIRECTOR

  • Jyrki Tenhunen, MD, PhD

    Tampere UH

    STUDY CHAIR

  • Anna-Maija Antman, MD

    Tampere UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

FI(2)