NCT01120730

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 1997

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1998

Completed
10.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
Last Updated

May 11, 2010

Status Verified

May 1, 2010

Enrollment Period

1.4 years

First QC Date

April 28, 2010

Last Update Submit

May 7, 2010

Conditions

SurvivalRenal Failure

Outcome Measures

Primary Outcomes (1)

  • Intensive care unit mortality

    28 days

    28 days

Secondary Outcomes (1)

  • fluid amount during the first 72 hours

    28 days

Study Arms (2)

HES

ACTIVE COMPARATOR

Fluid resuscitation with HES

Drug: fluid resuscitation

ringers lactat

PLACEBO COMPARATOR

Standard treatment

Drug: Fluid resuscitation

Interventions

Fluid resuscitationDRUG

fluid resuscitation with HES

HES

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 20584291DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Markus Béchir, md

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2010

First Posted

May 11, 2010

Study Start

April 1, 1997

Primary Completion

September 1, 1998

Study Completion

March 1, 2009

Last Updated

May 11, 2010

Record last verified: 2010-05

Locations

CH(1)