NCT07711405

Brief Summary

In patients with sepsis who are treated in the intensive care unit under invasive mechanical ventilation, the combined evaluation of ScvO₂ and PcvCO₂ may provide a comprehensive insight into tissue oxygenation and metabolic stress, allowing a more precise hemodynamic assessment in critically ill patients. The aim of this study is to evaluate the monitoring of ScvO₂, PcvCO₂, and EtCO₂ in intensive care patients in order to predict hemodynamic instability, 28-day mortality, and length of ICU stay, as well as to investigate their effects on cardiac output, tissue oxygenation, and hypoperfusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2026

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

December 25, 2025

Last Update Submit

July 14, 2026

Conditions

Keywords

sepsiscentral venous carbondioksidecarbondiokside gradientsepsis mortalitymortality predictioncentral venous to arterial carbondiokside

Outcome Measures

Primary Outcomes (1)

  • Correlation of the central venous-arterial carbon dioxide difference with 28-day mortality

    The primary outcome of this study is to evaluate the correlation between the central venous-arterial carbon dioxide difference and mortality in patients with sepsis admitted to the intensive care unit. The central venous-arterial carbon dioxide difference will be calculated using paired central venous and arterial blood gas samples obtained at predefined time points (at admission and at 6, 12, and 24 hours). Mortality will be assessed as 28-day all-cause mortality. The correlation between the carbon dioxide difference and mortality will be analyzed to determine its potential value as an indicator of mortality

    from march 2025 to january 2026

Secondary Outcomes (1)

  • Predictive accuracy of perfusion parameters and APACHE II score for 28-day mortality

    february 2025 to january 2026

Eligibility Criteria

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

İntubated icu patients who diagnosed with sepsis

You may qualify if:

  • Adult patients aged 18 years or older
  • Diagnosis of sepsis
  • Admission to the intensive care unit
  • Intubated and receiving invasive mechanical ventilation
  • Presence of a central venous catheter

You may not qualify if:

  • Patients younger than 18 years
  • Patients in whom a central venous catheter cannot be placed
  • Patients receiving oxygen therapy via face mask or nasal cannula
  • Patients treated with non-invasive mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

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
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2025

First Posted

July 17, 2026

Study Start

March 1, 2025

Primary Completion

September 20, 2025

Study Completion

January 13, 2026

Last Updated

July 17, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

No. Individual participant data will not be shared.

Locations