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Organ Donation and Hydrocortisone Treatment (HYDRO)

Primary Purpose

Brain Death

Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
hydrocortisone
sodium chloride
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Death focused on measuring brain death, subarachnoid hemorrhage, traumatic brain injury, brain injury, intracerebral hemorrhage, organ donation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kuopio University Hospital
  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

hydrocortisone treatment 50mg iv x4

Placebo iv every 6 hours

Outcomes

Primary Outcome Measures

dosage and time on norepinephrine treatment

Secondary Outcome Measures

Hormone levels and number of organs donated

Full Information

First Posted
May 7, 2008
Last Updated
April 3, 2015
Sponsor
Kuopio University Hospital
Collaborators
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00675272
Brief Title
Organ Donation and Hydrocortisone Treatment
Acronym
HYDRO
Official Title
Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Routine use of corticoids became standard therapy
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death
Keywords
brain death, subarachnoid hemorrhage, traumatic brain injury, brain injury, intracerebral hemorrhage, organ donation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
hydrocortisone treatment 50mg iv x4
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo iv every 6 hours
Intervention Type
Drug
Intervention Name(s)
hydrocortisone
Intervention Description
hydrocortisone 50mg iv. every 6 hours
Intervention Type
Drug
Intervention Name(s)
sodium chloride
Intervention Description
sodium chloride every 6 hours iv
Primary Outcome Measure Information:
Title
dosage and time on norepinephrine treatment
Time Frame
in ICU
Secondary Outcome Measure Information:
Title
Hormone levels and number of organs donated
Time Frame
Hospital treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stepani Bendel, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Esko Ruokonen, MD, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jyrki Tenhunen, MD, PhD
Organizational Affiliation
Tampere UH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna-Maija Antman, MD
Organizational Affiliation
Tampere UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Organ Donation and Hydrocortisone Treatment

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