NCT02631356

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

November 24, 2015

Last Update Submit

December 16, 2015

Conditions

Blood Viscosity

Outcome Measures

Primary Outcomes (1)

  • The patient's arterial blood viscosity (mpa.s) as tested by viscometer

    up to 5 months (after the infusion of succinylated gelatin )

Secondary Outcomes (1)

  • The patient's oxygen delivery index (DO2I) as calculated by Vigileo

    up to 5 months (after the infusion of succinylated gelatin )

Study Arms (2)

Ringer's lactate solution

PLACEBO COMPARATOR

Infusion of Ringer's lactate solution (10ml/kg) in the control group

Drug: Ringer's lactate solution

Succinylated gelatin

ACTIVE COMPARATOR

Infusion of Succinylated gelatin (10ml/kg) in the test group

Drug: Succinylated gelatin

Interventions

Ringer's lactate solutionDRUG
Ringer's lactate solution
Succinylated gelatinDRUG
Succinylated gelatin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Ringer's Lactatesuccinylated gelatin

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Xia Feng, MD. Ph.D.

CONTACT

13688877856fengxia@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 16, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Last Updated

December 17, 2015

Record last verified: 2015-12

Locations

CN(1)