NCT01515397

Comparison of Two Gelatine Solutions

Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypovolemia

Interventions

Type	Name	Description
DRUG	Gelofusine balanced	Gelofusine balanced combined with Sterofundin ISO
DRUG	Gelofusine 4%	Gelofusine 4% combined with NaCl 0.9%

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-01-24
• Last updated: 2013-11-27

Locations

2 sites across 1 country: Germany