NCT07516236

Brief Summary

This prospective observational diagnostic accuracy study investigates the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock, compared to measurements obtained using echocardiography (VTI) and cardiometry. We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Aug 2026Feb 2027

First Submitted

Initial submission to the registry

March 29, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

August 18, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

March 29, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

Diagnostic AccuracyDynamic Venous Oxygen SaturationFluid ResponsivenessSeptic Shock

Outcome Measures

Primary Outcomes (1)

  • Measuring dynamic central venous oxygen saturation (ScvO2) at baseline and after fluid challenge.

    After 30 mins

Secondary Outcomes (1)

  • Measuring Cardiac output by echocardiography or cardiometry at baseline and after fluid challenge.

    After 30 mins

Interventions

We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This single-center, prospective, observational study will be conducted in the Intensive Care Unit (ICU) at Menoufia University Hospitals. Adults spontaneously breathing patients with septic shock who undergo a fluid challenge as a part of their hemodynamic management in the first 24 hours will be eligible for enrollment. Ethical approval will be obtained from the ethics committee at the Menoufia Faculty of Medicine, and the study will follow ethical guidelines and secure approval from the Institutional Review Board (IRB). Written informed consent will be obtained from each participant or their legal surrogate before study inclusion.

You may qualify if:

  • Age \> 18 years
  • Diagnosis of septic shock according to Sepsis-3 criteria:
  • Suspected or confirmed infection o Requirement for vasopressors to maintain MAP \> 65 mmHg o Serum lactate \> 2 mmol/L despite adequate fluid resuscitation

You may not qualify if:

  • Pregnancy
  • Significant valvular heart disease.
  • Atrial fibrillation.
  • Inadequate echocardiographic window.
  • Ongoing bleeding or contraindication to fluid bolus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Menouf, Egypt

Location

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 29, 2026

First Posted

April 7, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

August 18, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations