Blood ViscosityPhase 4NCT02631356
The Effect of Succinylated Gelatin on the Blood Viscosity and Oxygen Delivery
A Phase 4 study testing Ringer's lactate solution and Succinylated gelatin in people with Blood Viscosity, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Viscosity
- What is being tested?
- Ringer's lactate solution and Succinylated gelatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Xia Feng, MD. Ph.D., 13688877856, fengxia@mail.sysu.edu.cn
About this study
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.
- Conditions
- Blood Viscosity
- Being tested
- Ringer's lactate solution, Succinylated gelatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's lactate solutionDrug
Succinylated gelatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ringer's lactate solution | Placebo comparator | Infusion of Ringer's lactate solution (10ml/kg) in the control group Receives: Drug: Ringer's lactate solution |
| Succinylated gelatin | Active comparator | Infusion of Succinylated gelatin (10ml/kg) in the test group Receives: Drug: Succinylated gelatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's arterial blood viscosity (mpa.s) as tested by viscometer
Measured: up to 5 months (after the infusion of succinylated gelatin )
Secondary outcomes (1)
The patient's oxygen delivery index (DO2I) as calculated by Vigileo
Measured: up to 5 months (after the infusion of succinylated gelatin )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood ViscosityStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Xia, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631356
- Sponsor's protocol ID
- 2015[22]
- Status last verified
- Dec 2015
- First submitted
- 24 Nov 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Succinylated Gelatin on the Blood Viscosity and Oxygen Delivery
- ClinicalTrials.gov ID
- NCT02631356
- Acronym / sponsor ID
- 2015[22]
- Conditions
- Blood Viscosity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (estimated)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer's lactate solution | Placebo comparator | Drug: Ringer's lactate solutionInfusion of Ringer's lactate solution (10ml/kg) in the control group |
| Succinylated gelatin | Active comparator | Drug: Succinylated gelatinInfusion of Succinylated gelatin (10ml/kg) in the test group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer's lactate solution | Drug | Ringer's lactate solution |
| Succinylated gelatin | Drug | Succinylated gelatin |
Primary outcome
The patient's arterial blood viscosity (mpa.s) as tested by viscometer
Time frame: up to 5 months (after the infusion of succinylated gelatin )
1 secondary outcome
The patient's oxygen delivery index (DO2I) as calculated by Vigileo
Time frame: up to 5 months (after the infusion of succinylated gelatin )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ringer's lactate solution and Succinylated gelatin in people with Blood Viscosity, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xia Feng, MD. Ph.D. (13688877856, fengxia@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient's arterial blood viscosity (mpa.s) as tested by viscometer (time frame: up to 5 months (after the infusion of succinylated gelatin )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.