The Effect of Succinylated Gelatin on the Blood Viscosity and Oxygen Delivery

Phase 4

• Conditions: Blood Viscosity
• Interventions: Drug: Ringer's lactate solution; Drug: Succinylated gelatin

• Registration Number: NCT02631356
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

The study is to investigate the effect of succinylated gelatin on the blood viscosity and oxygen delivery in patients during surgeries, so as to have a better understanding of the safety in the use of succinylated gelatin for surgical patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-24
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-17
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients between the ages of 18 years and 60 years
• ASA physical status I and II
• surgical procedures requiring general anesthesia with continuous CVP and arterial pressure monitoring

Exclusion Criteria

• Patients younger than 16 y or older than 60 y
• Body Mass Index (BMI) <18 or >30
• Allergy to any of the drugs used
• Severe cardiovascular dysfunction
• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer's lactate solution	Ringer's lactate solution	Infusion of Ringer's lactate solution (10ml/kg) in the control group
Succinylated gelatin	Succinylated gelatin	Infusion of Succinylated gelatin (10ml/kg) in the test group

Primary Outcome Measures

Name	Time	Method
The patient's arterial blood viscosity (mpa.s) as tested by viscometer	up to 5 months (after the infusion of succinylated gelatin )

Secondary Outcome Measures

Name	Time	Method
The patient's oxygen delivery index (DO2I) as calculated by Vigileo	up to 5 months (after the infusion of succinylated gelatin )

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China