The Effect of Succinylated Gelatin on the Blood Viscosity... | NCT02631356

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

NCT02631356

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Dec 17, 2015Estimated

Enrollment

12Estimated

Phase

Phase 4

Conditions

Blood Viscosity

Interventions

Ringer's lactate solution
Succinylated gelatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

May 2016Estimated

Completion Date

Not provided

First Submitted Date

Nov 24, 2015

First Submission Date that Met QC Criteria

Dec 11, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2015

Last Update Posted Date

Dec 17, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Feng Xia, Professor, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ringer's lactate solution	Drug		Ringer's lactate solution
Succinylated gelatin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xia Feng, MD. Ph.D.	Contact	13688877856		fengxia@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Sun Yat-Sen University	Recruiting	Guangzhou	Guangdong	510080	China

Intervention Browse Module

MeSH Terms

ID	Term
D000077325	Ringer's Lactate
C060085	succinylated gelatin

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided