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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by University of Zurich.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012648
First Posted: November 13, 2009
Last Update Posted: March 16, 2011
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.
Information provided by:
University of Zurich
  Purpose

RCT colloids versus cristalloids only in severe burn victims.

  • Trial with medicinal product

Condition Intervention Phase
Burns 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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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")
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01012648


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

Locations
Switzerland
Surgical ICU Recruiting
Zurich, Switzerland, 8091
Contact: Markus Béchir, M.D.         
Principal Investigator: Markus Béchir, M.D.         
Sponsors and Collaborators
University of Zurich
Investigators
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
First Submitted: October 29, 2009
First Posted: November 13, 2009
Last Update Posted: March 16, 2011
Last Verified: March 2011