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

Primary Purpose

Burns

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Fluid resuscitation
HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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")

Sites / Locations

  • Surgical ICURecruiting

Outcomes

Primary Outcome Measures

Reduced amount of fluids given

Secondary Outcome Measures

Full Information

First Posted
October 29, 2009
Last Updated
March 15, 2011
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01012648
Brief Title
Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

5. Study Description

Brief Summary
RCT colloids versus cristalloids only in severe burn victims. Trial with medicinal product

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluid resuscitation
Intervention Description
Volume resuscitation
Intervention Type
Drug
Intervention Name(s)
HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
Intervention Description
Volume Resuscitation
Primary Outcome Measure Information:
Title
Reduced amount of fluids given
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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")
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
01 Studienregister MasterAdmins
Phone
+41 (0)44 255 11 11
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Béchir, M.D:
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical ICU
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Béchir, M.D.
First Name & Middle Initial & Last Name & Degree
Markus Béchir, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
24365167
Citation
Bechir M, Puhan MA, Fasshauer M, Schuepbach RA, Stocker R, Neff TA. Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury: a randomized, controlled, double-blind clinical trial. Crit Care. 2013 Dec 23;17(6):R299. doi: 10.1186/cc13168.
Results Reference
derived

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

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