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Clinical Trial Summary

This clinical study compares two fluid resuscitation treatments in patients suffering from burns injury. The treatments are Volulyte® and Human Serum Albumin (HSA) which will be administered as infusion solutions. It will be evaluated whether Volulyte® is effective and safe, and provides any benefit.


Clinical Trial Description

Severe burns injury presents a unique resuscitation problem due to simultaneous loss of electrolyte and protein-rich exudate from the burn wound itself and leakage of fluid and protein from the circulation into the interstitial compartment. In the post shock phase of burn resuscitation, patients frequently suffer oedema of unburned tissues and organs and a positive fluid balance of many litres. This pilot study will compare two burns fluid resuscitation regimes (supplementation with 6% HES 130/0.4 in an isotonic electrolyte solution, Volulyte 6%, versus supplementation with Human Serum Albumin, HSA 50g/L) on patient outcome with particular regard to fluid balance at 24 hours after burns injury (primary variable). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01689506
Study type Interventional
Source Fresenius Kabi
Contact
Status Terminated
Phase Phase 4
Start date December 2012
Completion date September 2013

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