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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Zurich.
Recruitment status was  Recruiting
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
First received: October 29, 2009
Last updated: March 15, 2011
Last verified: March 2011

RCT colloids versus cristalloids only in severe burn victims.

  • Trial with medicinal product

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Reduced amount of fluids given [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: November 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fluid resuscitation
    Volume resuscitation
    Drug: HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
    Volume Resuscitation

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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")
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01012648

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

Surgical ICU Recruiting
Zurich, Switzerland, 8091
Contact: Markus Béchir, M.D.         
Principal Investigator: Markus Béchir, M.D.         
Sponsors and Collaborators
University of Zurich
Principal Investigator: Markus Béchir, M.D: UniversitaetsSpital Zuerich
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Béchir Markus, MD, Intensivmedizin
ClinicalTrials.gov Identifier: NCT01012648     History of Changes
Other Study ID Numbers: BURN 
Study First Received: October 29, 2009
Last Updated: March 15, 2011
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on May 26, 2016