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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01120730
First received: April 28, 2010
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
  Purpose

HES 200/0.5 10% is equal to ringers lactat solution.


Condition Intervention Phase
Survival
Renal Failure
 Drug: fluid resuscitation
Drug: Fluid resuscitation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Intensive care unit mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    28 days


Secondary Outcome Measures:
  • fluid amount during the first 72 hours [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Fluid resuscitation after burn


Enrollment: 28
Study Start Date: April 1997
Study Completion Date: March 2009
Primary Completion Date: September 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120730

Locations
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Markus Béchir, md University of Zurich
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas A. Neff, Surgical ICU University Hospital Zurich
ClinicalTrials.gov Identifier: NCT01120730     History of Changes
Other Study ID Numbers: USZ-BURN, 97/x
Study First Received: April 28, 2010
Last Updated: May 7, 2010
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Burns
Renal Insufficiency
Wounds and Injuries
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013