Organ Donation and Hydrocortisone Treatment (HYDRO)

April 3, 2015 updated by: Stepani Bendel, Kuopio University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • Kuopio University Hospital
      • Tampere, Finland
        • Tampere university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
hydrocortisone treatment 50mg iv x4
Drug: hydrocortisone
hydrocortisone 50mg iv. every 6 hours
Placebo Comparator: 2
Placebo iv every 6 hours
Drug: sodium chloride
sodium chloride every 6 hours iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dosage and time on norepinephrine treatment
Time Frame: in ICU
in ICU

Secondary Outcome Measures

Outcome Measure
Time Frame
Hormone levels and number of organs donated
Time Frame: Hospital treatment
Hospital treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Tampere University Hospital

Investigators

  • Study Director: Stepani Bendel, MD, Kuopio University Hospital
  • Study Director: Esko Ruokonen, MD, PhD, Kuopio University Hospital
  • Study Chair: Jyrki Tenhunen, MD, PhD, Tampere UH
  • Principal Investigator: Anna-Maija Antman, MD, Tampere UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 8, 2008

First Posted (Estimate)

May 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 3, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5070197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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