ShockNCT07670390
Tissue Perfusion Pressure for Predicting Fluid Responsiveness in Patients With Shock
An observational study of Shock, run by Jingyuan,Xu.
Trial summary
This prospective observational study aims to evaluate the ability of tissue perfusion pressure (TPP) to predict fluid responsiveness in critically ill patients with shock and tissue hypoperfusion. Eligible patients requiring fluid resuscitation will undergo a standardized fluid challenge test. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shock
- What is being tested?
- When the attending physician determines that fluid resuscitation is clinically indicated: Patients will remain in the supine position. Crystalloid solution will be administered intravenously via centr
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of critically ill adult patients with shock and tissue hypoperfusion admitted to the Intensive Care Unit of Zhongda Hospital, Southeast University. Patients requiring fluid resuscitation and invasive hemodynamic monitoring as part of routine clinical care will be screened for eligibility and consecutively enrolled in this prospective observational study.
Who may be able to join
- Age ≥18 years
- Admitted to the Intensive Care Unit (ICU)
- Diagnosed with shock and evidence of tissue hypoperfusion
- Judged by the treating physician to require fluid resuscitation
- Receiving invasive hemodynamic monitoring
- Written informed consent obtained from the patient or legally authorized representative
Who cannot join
- Pregnancy
- Immediate requirement for extracorporeal life support, including: VV-ECMO, VA-ECMO, Ventricular assist devices
- Expected survival less than 72 hours
- Absence of invasive arterial pressure monitoring or arterial waveform availability <25%
- Any condition deemed unsuitable for study participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tissue Perfusion Pressure for Predicting Fluid Responsiveness in Patients With Shock: A Prospective Observational Study
This prospective observational study aims to evaluate the ability of tissue perfusion pressure (TPP) to predict fluid responsiveness in critically ill patients with shock and tissue hypoperfusion. Eligible patients requiring fluid resuscitation will undergo a standardized fluid challenge test. Hemodynamic parameters, including cardiac output and TPP, will be recorded before and after fluid administration. Fluid responsiveness will be defined according to the change in cardiac output following fluid loading. The study will assess the correlation between changes in TPP and cardiac output and evaluate the diagnostic performance of TPP for predicting fluid responsiveness. The results may support the use of TPP as a practical and physiologically relevant parameter for individualized fluid management in patients with shock.
- Conditions
- Shock
- Being tested
- When the attending physician determines that fluid resuscitation is clinically indicated: Patients will remain in the supine position. Crystalloid solution will be administered intravenously via centr
- Keywords
- shock, tissue perfusion pressure
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
When the attending physician determines that fluid resuscitation is clinically indicated: Patients will remain in the supine position. Crystalloid solution will be administered intravenously via centrBehavioural
| Study group | Role | What they receive |
|---|---|---|
| all | Not described Receives: Behavioral: When the attending physician determines that fluid resuscitation is clinically indicated: Patients will remain in the supine position. Crystalloid solution will be administered intravenously via centr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Δ Cardiac output
Measured: Periprocedural
Δ Tissue perfusion pressure
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingyuan,Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingyuan,Xu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670390
- Sponsor's protocol ID
- 2025ZDSYLL481-P01
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Perfusion Pressure for Predicting Fluid Responsiveness in Patients With Shock: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07670390
- Acronym / sponsor ID
- 2025ZDSYLL481-P01
- Conditions
- Shock
- Keywords
- shock, tissue perfusion pressure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Jingyuan,XuUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 26 Jun 2026 (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.
This prospective observational study aims to evaluate the ability of tissue perfusion pressure (TPP) to predict fluid responsiveness in critically ill patients with shock and tissue hypoperfusion. Eligible patients requiring fluid resuscitation will undergo a standardized fluid challenge test. Hemodynamic parameters, including cardiac output and TPP, will be recorded before and after fluid administration. Fluid responsiveness will be defined according to the change in cardiac output following fluid loading. The study will assess the correlation between changes in TPP and cardiac output and evaluate the diagnostic performance of TPP for predicting fluid responsiveness. The results may support the use of TPP as a practical and physiologically relevant parameter for individualized fluid management in patients with shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all | – | Behavioral: When the attending physician determines that fluid resuscitation is clinically indicated: Patients will remain in the supine position. Crystalloid solution will be administered intravenously via centr |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of critically ill adult patients with shock and tissue hypoperfusion admitted to the Intensive Care Unit of Zhongda Hospital, Southeast University. Patients requiring fluid resuscitation and invasive hemodynamic monitoring as part of routine clinical care will be screened for eligibility and consecutively enrolled in this prospective observational study.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Admitted to the Intensive Care Unit (ICU)
- Diagnosed with shock and evidence of tissue hypoperfusion
- Judged by the treating physician to require fluid resuscitation
- Receiving invasive hemodynamic monitoring
Key exclusion criteria (5 listed)
- Pregnancy
- Immediate requirement for extracorporeal life support, including: VV-ECMO, VA-ECMO, Ventricular assist devices
- Expected survival less than 72 hours
- Absence of invasive arterial pressure monitoring or arterial waveform availability <25%
- Any condition deemed unsuitable for study participation by the investigator.
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 |
|---|---|---|
| When the attending physician determines that fluid resuscitation is clinically indicated: Patients will remain in the supine position. Crystalloid solution will be administered intravenously via centr | Behavioural | all |
Primary outcome
Δ Cardiac output
Time frame: Periprocedural
Δ Tissue perfusion pressure
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Jingyuan,Xu.
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 6 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: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyuan Xu (8602583262550, xujingyuanmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Δ Cardiac output (time frame: Periprocedural). The study lists 2 primary outcomes in all. 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 26 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.