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

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RCT colloids versus cristalloids only in severe burn victims.

• Trial with medicinal product

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich

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")