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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
University of Zurich

Brief Summary:

RCT colloids versus cristalloids only in severe burn victims.

  • Trial with medicinal product

Condition or disease Intervention/treatment Phase
Burns Drug: Fluid resuscitation Drug: HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2009
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Intervention Details:
  • Drug: Fluid resuscitation
    Volume resuscitation
  • Drug: HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
    Volume Resuscitation

Primary Outcome Measures :
  1. Reduced amount of fluids given [ Time Frame: 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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")

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01012648

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Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

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Surgical ICU Recruiting
Zurich, Switzerland, 8091
Contact: Markus Béchir, M.D.         
Principal Investigator: Markus Béchir, M.D.         
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Markus Béchir, M.D: UniversitaetsSpital Zuerich
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Béchir Markus, MD, Intensivmedizin Identifier: NCT01012648    
Other Study ID Numbers: BURN
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Wounds and Injuries