SepsisNCT05118646
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
A study testing sublingual microcirculation, and hemodynamic monitoring in people with Sepsis, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis
- What is being tested?
- sublingual microcirculation, and hemodynamic monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2021
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients fulfilled the diagnostic criteria of septic shock.
Who cannot join
- declined to participate
- pregnant
- patients who were younger than 18 years old
- active bleeding
- septic shock is diagnosed for more than 4 hours
- patients are expected to be die within 24hours
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Lina Zhang
About this study
Official title: Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Early Fluid Resuscitation in Patients With Septic Shock
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
Read the detailed description
Objectives: Comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock.
Intervention:
- Microcirculation-oriented resuscitation group: When the system hemodynamics meets the standard of EDGT, the microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV > 68%).
- Control group: The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.
Primary outcome:
(1)change in SOFA score at 72h (2)30-day mortality
- Conditions
- Sepsis
- Being tested
- sublingual microcirculation,, hemodynamic monitoring
- Keywords
- Septic shock; Sublingual Microcirculation
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual microcirculation,Device
Avoiding pressure artifacts, clear stable microvascular images were taken for a minimum of 20 seconds of the left, middle, and right sections of the tongue.
hemodynamic monitoringDevice
Arterial blood lactic acid (Lac), central venous oxygen saturation (ScvO2), hematocrit (HCT) and entral venous-to-arterial carbon dioxide partial pressure difference (Pcv-aCO2) will be measured employing a bedside blood gas machine on admission and six hours following admission.
| Study group | Role | What they receive |
|---|---|---|
| Microcirculation-oriented resuscitation group | Experimental | The microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV > 68%). Receives: Device: sublingual microcirculation,; Device: hemodynamic monitoring |
| Control group | Other | The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters. Receives: Device: hemodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in SOFA score
△SOFA
Measured: 72h
Secondary outcomes (1)
30-day mortality
mortality
Measured: 30d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lina Zhang, MD., Principal investigator, XiangYa Hospital CentralSouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118646
- Sponsor's protocol ID
- 202006141
- Status last verified
- Dec 2020
- First submitted
- 1 Nov 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Early Fluid Resuscitation in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT05118646
- Acronym / sponsor ID
- 202006141
- Conditions
- Sepsis
- Keywords
- Septic shock; Sublingual Microcirculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 12 Nov 2021 (actual)
- 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.
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
Detailed description
Objectives: Comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock.
Intervention:
- Microcirculation-oriented resuscitation group: When the system hemodynamics meets the standard of EDGT, the microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV > 68%).
- Control group: The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.
Primary outcome:
(1)change in SOFA score at 72h (2)30-day mortality
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microcirculation-oriented resuscitation group | Experimental | Device: sublingual microcirculation,, Device: hemodynamic monitoringThe microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV > 68%). |
| Control group | Other | Device: hemodynamic monitoringThe standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients fulfilled the diagnostic criteria of septic shock.
Key exclusion criteria (6 listed)
- declined to participate
- pregnant
- patients who were younger than 18 years old
- active bleeding
- septic shock is diagnosed for more than 4 hours
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 |
|---|---|---|
| sublingual microcirculation,Avoiding pressure artifacts, clear stable microvascular images were taken for a minimum of 20 seconds of the left, middle, and right sections of the tongue. | Device | Microcirculation-oriented resuscitation group |
| hemodynamic monitoringArterial blood lactic acid (Lac), central venous oxygen saturation (ScvO2), hematocrit (HCT) and entral venous-to-arterial carbon dioxide partial pressure difference (Pcv-aCO2) will be measured employing a bedside blood gas machine on admission and six hours following admission. | Device | Control group, Microcirculation-oriented resuscitation group |
Primary outcome
change in SOFA score
Time frame: 72h
△SOFA
1 secondary outcome
30-day mortality
Time frame: 30d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
lina Zhang, MD. principal investigator
XiangYa Hospital CentralSouth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sublingual microcirculation, and hemodynamic monitoring in people with Sepsis, run by Xiangya Hospital of Central South 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 1 inclusion and 6 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 12 Nov 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Lina Zhang, MD. (+8615874875763, zln7095@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in SOFA score (time frame: 72h). 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 12 Nov 2021.