Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury

May 7, 2010 updated by: University of Zurich
HES 200/0.5 10% is equal to ringers lactat solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

30 Patients were enrolled to the study, either to the hyperoncotic HES 200/0.5 (10%) group or to the crystalloids only group. After a treatment protocol of 72 hours we collected data about complications like pulmonary failure and abdominal compartment syndrome. Furthermore, we addressed the question of incidence of mortality and renal failure.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 3

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

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All burn victims with burned surface area bigger than 20%

Exclusion Criteria:

  • Pregnancy

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: HES
Fluid resuscitation with HES
Drug: fluid resuscitation
fluid resuscitation with HES
PLACEBO_COMPARATOR: ringers lactat
Standard treatment
Drug: Fluid resuscitation
Fluid resuscitation in standardized fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive care unit mortality
Time Frame: 28 days
28 days
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fluid amount during the first 72 hours
Time Frame: 28 days
Fluid resuscitation after burn
28 days

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Markus Béchir, md, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 1997

Primary Completion (ACTUAL)

September 1, 1998

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (ESTIMATE)

May 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 11, 2010

Last Update Submitted That Met QC Criteria

May 7, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USZ-BURN
  • 97/x (OTHER: kantonale Ethikkommision)

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.

Clinical Trials on Renal Failure

Clinical Trials on fluid resuscitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe