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

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ClinicalTrials.gov Identifier: NCT01012648
Recruitment Status : Unknown
Verified March 2011 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : November 13, 2009
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:
University of Zurich

October 29, 2009
November 13, 2009
March 16, 2011
November 2009
January 2013   (Final data collection date for primary outcome measure)
Reduced amount of fluids given [ Time Frame: 3 days ]
Reduced amount of fluids given
Complete list of historical versions of study NCT01012648 on ClinicalTrials.gov Archive Site
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Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury
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RCT colloids versus cristalloids only in severe burn victims.

  • Trial with medicinal product
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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Burns
  • Drug: Fluid resuscitation
    Volume resuscitation
  • Drug: HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
    Volume Resuscitation
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Béchir 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
48
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January 2013
January 2013   (Final data collection date for primary outcome measure)

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")
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01012648
BURN
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Béchir Markus, MD, Intensivmedizin
University of Zurich
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Principal Investigator: Markus Béchir, M.D: UniversitaetsSpital Zuerich
University of Zurich
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP