Burns
Conditions
Brief summary
RCT colloids versus cristalloids only in severe burn victims. * Trial with medicinal product
Interventions
DRUGFluid resuscitation
Volume resuscitation
DRUGHES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
Volume Resuscitation
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduced amount of fluids given | 3 days |
Countries
Switzerland
Contacts
Primary Contact01 Studienregister MasterAdmins
Outcome results
None listed