Study on the Efficacy and Safety of Gelaspan

Phase 3

Completed

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

• Registration Number: NCT02808325
• Lead Sponsor: B. Braun Medical LLC

Brief Summary

It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-21
• Status Verified: 2017-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Base Excess	Change in base excess from baseline to end of surgery

Secondary Outcome Measures

Name	Time	Method
Renal Function	until 12 hours after end of surgery
Arterial blood gas analysis	until 12 hours after end of surgery
Coagulation status	until 12 hours after end of surgery
Base Excess	Change in base excess from baseline to 12 hours after end of surgery
Hemodynamics	until 12 hours after end of surgery
Adverse events	until 12 hours after end of surgery

Trial Locations

Locations (3)

North-Western Federal Medical Research Center n.a. V.A. Almazov; 🇷🇺 Saint-Petersburg, Russian Federation

Road Clinical Hospital of JSC "Russian Railways; 🇷🇺 Saint-Petersburg, Russian Federation

City Clinical Oncology Dispensary; 🇷🇺 Saint-Petersburg, Russian Federation