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

University of Zurich (UZH)

Status and phase: Unknown; Phase 4

Conditions: Burns

Treatments: Drug: Fluid resuscitation; Drug: HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01012648

BURN

Details and patient eligibility

About

RCT colloids versus cristalloids only in severe burn victims.

• Trial with medicinal product

Enrollment: 48 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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")

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind