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
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01012648
First received: October 29, 2009
Last updated: March 15, 2011
Last verified: March 2011
  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
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
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Zurich

Additional 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 October 30, 2014