ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01120730
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : May 11, 2010
Sponsor:
Information provided by:
University of Zurich

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

Condition or disease Intervention/treatment Phase
Survival Renal Failure Drug: fluid resuscitation Drug: Fluid resuscitation Phase 3

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury
Study Start Date : April 1997
Actual Primary Completion Date : September 1998
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Intensive care unit mortality [ Time Frame: 28 days ]
    28 days


Secondary Outcome Measures :
  1. fluid amount during the first 72 hours [ Time Frame: 28 days ]
    Fluid resuscitation after burn



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120730


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

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 ( Other Identifier: kantonale Ethikkommision )
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: May 11, 2010
Last Verified: May 2010

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