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NCT01120730 Clinical Trial

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

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01120730
Other study ID # USZ-BURN
Secondary ID 97/x
Status Completed
Phase Phase 3
First received April 28, 2010
Last updated May 7, 2010
Start date April 1997
Est. completion date March 2009

Study information
Verified date May 2010
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date March 2009
Est. primary completion date September 1998
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• fluid resuscitation
fluid resuscitation with HES
• Fluid resuscitation
Fluid resuscitation in standardized fashion

Locations
Country Name City State
Switzerland University Hospital Zurich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intensive care unit mortality 28 days 28 days Yes
Secondary fluid amount during the first 72 hours Fluid resuscitation after burn 28 days Yes
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