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

NCT ID: NCT01120730

Last Updated: 2010-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-04-30

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Survival Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HES

Fluid resuscitation with HES

Group Type ACTIVE_COMPARATOR

fluid resuscitation

Intervention Type DRUG

fluid resuscitation with HES

ringers lactat

Standard treatment

Group Type PLACEBO_COMPARATOR

Fluid resuscitation

Intervention Type DRUG

Fluid resuscitation in standardized fashion

Interventions

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fluid resuscitation

fluid resuscitation with HES

Intervention Type DRUG

Fluid resuscitation

Fluid resuscitation in standardized fashion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Surgical ICU University Hospital Zurich

Principal Investigators

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Markus Béchir, md

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 20584291 (View on PubMed)

Other Identifiers

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97/x

Identifier Type: OTHER

Identifier Source: secondary_id

USZ-BURN

Identifier Type: -

Identifier Source: org_study_id

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