Back to resultsFluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury
Primary Purpose
Survival, Renal Failure
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
fluid resuscitation
Fluid resuscitation
Sponsored by
About this trial
This is an interventional treatment trial for Survival
Eligibility Criteria
Inclusion Criteria:
- All burn victims with burned surface area bigger than 20%
Exclusion Criteria:
- Pregnancy
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
HES
ringers lactat
Arm Description
Fluid resuscitation with HES
Standard treatment
Outcomes
Primary Outcome Measures
Intensive care unit mortality
28 days
Secondary Outcome Measures
fluid amount during the first 72 hours
Fluid resuscitation after burn
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01120730
Brief Title
Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury
Official Title
Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
September 1998 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
HES 200/0.5 10% is equal to ringers lactat solution.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survival, Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HES
Arm Type
Active Comparator
Arm Description
Fluid resuscitation with HES
Arm Title
ringers lactat
Arm Type
Placebo Comparator
Arm Description
Standard treatment
Intervention Type
Drug
Intervention Name(s)
fluid resuscitation
Intervention Description
fluid resuscitation with HES
Intervention Type
Drug
Intervention Name(s)
Fluid resuscitation
Intervention Description
Fluid resuscitation in standardized fashion
Primary Outcome Measure Information:
Title
Intensive care unit mortality
Description
28 days
Time Frame
28 days
Secondary Outcome Measure Information:
Title
fluid amount during the first 72 hours
Description
Fluid resuscitation after burn
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All burn victims with burned surface area bigger than 20%
Exclusion Criteria:
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Béchir, md
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20584291
Citation
Bechir M, Puhan MA, Neff SB, Guggenheim M, Wedler V, Stover JF, Stocker R, Neff TA. Early fluid resuscitation with hyperoncotic hydroxyethyl starch 200/0.5 (10%) in severe burn injury. Crit Care. 2010;14(3):R123. doi: 10.1186/cc9086. Epub 2010 Jun 28.
Results Reference
derived
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Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury
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