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

December 16, 2015 updated by: Feng Xia, First Affiliated Hospital, Sun Yat-Sen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Ringer's lactate solution
Infusion of Ringer's lactate solution (10ml/kg) in the control group
Drug: Ringer's lactate solution
Active Comparator: Succinylated gelatin
Infusion of Succinylated gelatin (10ml/kg) in the test group
Drug: Succinylated gelatin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2015[22]

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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