NCT07670390

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Jun 2028

First Submitted

Initial submission to the registry

June 4, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

June 4, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

shocktissue perfusion pressure

Outcome Measures

Primary Outcomes (2)

  • Δ Cardiac output

    Periprocedural

  • Δ Tissue perfusion pressure

    Periprocedural

Study Arms (1)

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

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Zhongda Hospital

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 26, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share