Comparison of Two Gelatine Solutions

Phase 3

Completed

• Conditions: Hypovolemia
• Interventions: Drug: Gelofusine balanced; Drug: Gelofusine 4%

• Registration Number: NCT01515397
• Lead Sponsor: B. Braun Melsungen AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-24
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balanced gelatine solution	Gelofusine balanced	isotonic colloidal volume substitute
non-balanced gelatine solution	Gelofusine 4%	colloidal volume substitute

Primary Outcome Measures

Name	Time	Method
base excess [mmol/l]	Change from baseline at end of surgery, an expected average of 2 hours surgery
chloride [mmol/l]	Change from baseline at end of surgery, an expected average of 2 hours surgery

Secondary Outcome Measures

Name	Time	Method
arterial blood gase analyses	until 12 hours after surgery
coagulation status	until 12 hours after surgery
renal function	until 12 hours after surgery
adverse events	until 12 hours after surgery
hemodynamics (systolic and diastolic blood pressure)	until 12 hours after surgery
time on ventilation	until 12 hours after surgery

Trial Locations

Locations (2)

Universitätsklinikum Aachen, Klinik für Anästhesiologie; 🇩🇪 Aachen, Germany

Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main; 🇩🇪 Frankfurt/Main, Germany