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

Blood Viscosity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02631356
• Other study ID #: 2015[22]
• Status: Recruiting
• Phase: Phase 4
• First received: November 24, 2015
• Last updated: December 16, 2015
• Start date: November 2015

Study information

• Verified date: December 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Xia Feng, MD. Ph.D.
• Phone: 13688877856
• Email: fengxia[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Viscosity

Intervention

Drug:
• Ringer's lactate solution

• Succinylated gelatin

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patient's arterial blood viscosity (mpa.s) as tested by viscometer		up to 5 months (after the infusion of succinylated gelatin )	No
Secondary	The patient's oxygen delivery index (DO2I) as calculated by Vigileo		up to 5 months (after the infusion of succinylated gelatin )	No