Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-01-31

Brief Summary

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RCT colloids versus cristalloids only in severe burn victims.

* Trial with medicinal product

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Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Fluid resuscitation

Volume resuscitation

Intervention Type DRUG

HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution

Volume Resuscitation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Deep burn injury more than 15% of total body surface area (2nd and 3rd degree burns)
* Informed consent (via deferred consent, if necessary, according to Swiss HMG § 55 and 56).
* Patients or relatives can understand the study information and the provided information in German language

Exclusion Criteria

* Patients expected to succumb within the next 24 to 36 hours, i.e. whole body burn trauma, palliative care situation
* Pregnancy
* No informed consent
* Known allergic reaction to HES
* Patients or patient's relatives, who do not understand the German language and therefore the study information, can not be provided in a legally correct manner.
* Patients with contraindications for balanced 6% HES 130/0.4, i.e. heart failure, pulmonary edema, intracerebral bleeding, acute renal failure, severe hypernatraemia and other severe electrolyte imbalances, severe von-Willebrand Syndrome and acute liver failure (see "Arzneimittelkompendium der Schweiz® - Documed")

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No