TerminatedInterventionalPhase 4Updated Jan 29, 2025
Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury | NCT01012648 | Trialant
Unknown statusInterventionalPhase 4Updated Mar 16, 2011
Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury
ClinicalTrials.gov ID
NCT01012648
Lead Sponsor
University of ZurichOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 4
Enrollment
48Estimated
Last Update Posted
Mar 16, 2011Estimated
Start Date
Nov 2009
Primary Completion Date
Jan 2013Estimated
Completion Date
Jan 2013Estimated
Brief Summary
RCT colloids versus cristalloids only in severe burn victims.
Trial with medicinal product
Burns
Fluid resuscitation
HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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")