MedDataX Logo

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

NCT ID: NCT02631356

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Viscosity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ringer's lactate solution

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

Group Type PLACEBO_COMPARATOR

Ringer's lactate solution

Intervention Type DRUG

Succinylated gelatin

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

Group Type ACTIVE_COMPARATOR

Succinylated gelatin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ringer's lactate solution

Intervention Type DRUG

Succinylated gelatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Feng Xia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xia Feng, MD. Ph.D.

Role: CONTACT

Phone: 13688877856

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xia Feng, MD. Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015[22]

Identifier Type: -

Identifier Source: org_study_id