drugset / Trial / NCT01515397

Comparison of Two Gelatine Solutions

NCT01515397 ↗

Phase 3 Completed 40 enrolled B. Braun Melsungen AG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.

Timeline

Start
2011-12
Primary completion
2013-01
Completion
2013-01

Outcome

Met primary endpoint

paper demonstrated significant smaller impact on blood gas analytic parameters in the primary endpoints BE and serum chloride when compared to a non-balanced gelatine solution 4% combined with NaCl 0.9%. PMID 31034525 ↗

paper were significantly different (p = 0.0117 and p = 0.0045, respectively). PMID 31034525 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gelofusine 4% Unknown — Intravenous
Subject Gelofusine balanced Unknown — Intravenous
Subject NaCl Unknown — Intravenous
Subject Sterofundin ISO Other / unclassified — Intravenous

Indications

No indication recorded.