drugset / Trial / NCT01012648

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

NCT01012648 ↗

Phase 4 Unknown 48 enrolled University of Zurich
RandomizedSingle-groupQuadruple-blindTreatment

Summary

RCT colloids versus cristalloids only in severe burn victims. * Trial with medicinal product

Timeline

Start
2009-11
Primary completion
2013-01
Completion
2013-01

Outcome

Missed primary endpoint

paper Three-day totals of administered resuscitation fluid (medians) were 21,190 mL in the lactated Ringer's group and 19,535 mL in the HES group (HES: -1,213 mL; P = 0.39). PMID 24365167 ↗

paper There was no evidence that early fluid resuscitation with balanced HES 130/0.4 (6%) in addition to lactated Ringer's solution would lead to a volume-sparing effect PMID 24365167 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Volulyte Other / unclassified 6 % —
Background Lactated Ringer's solution Unknown — —

Indications

No indication recorded.