NCT07096284

Brief Summary

The ratio of the venous-arterial carbon dioxide partial pressure difference to the arteriovenous oxygen content difference (Pv-aCO₂/Ca-vO₂) may be a marker of anaerobic metabolism in patients with acute circulatory failure. This study aims to assess the prognostic value of the PvCO2-PaCO2/CaO2-CvO2 in the early phase of septic shock.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

3 active sites

Status
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 Progress90%
Jan 2025Jun 2026

First Submitted

Initial submission to the registry

December 26, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

December 26, 2024

Last Update Submit

March 28, 2026

Conditions

Keywords

sepsisanaerobic metabolism

Outcome Measures

Primary Outcomes (1)

  • Prognostic value of PvCO2-PaCO2/Ca O2-CvO2 in patients with septic shock

    The ability of PvCO2-PaCO2/Ca O2-CvO2 to predict mortality in patients with septic shock. These biological values will be measure using arterial and central venous blood gaz.

    From patient inclusion (baseilie = H0) then at H2, H6, H 12 and H24 (H = hours)

Study Arms (1)

Adult patients with septic shock.

Patients aged over 18 years presenting with septic shock. defined as sepsis with persistent hypotension requiring vasopressors to maintain a mean arterial pressure (MAP) ≥ 65 mmHg and lactatemia \> 2 mmol/L despite adequate fluid resuscitation.

Diagnostic Test: PvCO2-PaCO2/CaO2-CvO2 ratio

Interventions

Patients diagnosed with septic shock will undergo serial measurements of arterial and venous blood gas analyses, arterial lactate levels, and calculation of the Pv-aCO₂/Ca-vO₂ ratio at predefined time points: H0 (baseline), H2, H6, H12, and H24. Calculation Formulas: 1. Arterial Oxygen Content (CaO₂):CaO2 = SaO2 × Hb × 1,34 + PaO2 × 0,0031 2. Venous Oxygen Content (CvO₂):CvO2 = SvO2 × Hb × 1,34 + PvO2 × 0,0031 3. Pv-aCO₂/Ca-vO₂ Ratio: P(v-a) CO2/C(a-v)O2=(PcvCO2-PaCO2)/(CaO2 -CcvO2).

Adult patients with septic shock.

Eligibility Criteria

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

Patients aged over 18 years presenting with septic shock, defined as sepsis with persistent hypotension requiring vasopressors to maintain a mean arterial pressure (MAP) ≥ 65 mmHg and lactatemia \> 2 mmol/L despite adequate fluid resuscitation. Sepsis is defined by the presence of a suspected or confirmed infectious source associated with organ dysfunction (neurological, respiratory, renal, hepatic, or hematological). \[Sepsis 3 criteria\]

You may qualify if:

  • Patients aged over 18 years presenting with septic shock, defined as sepsis with persistent hypotension requiring vasopressors to maintain a mean arterial pressure (MAP) ≥ 65 mmHg and lactatemia \> 2 mmol/L despite adequate fluid resuscitation. Sepsis is defined by the presence of a suspected or confirmed infectious source associated with organ dysfunction (neurological, respiratory, renal, hepatic, or hematological). \[Sepsis 3 criteria\]

You may not qualify if:

  • Absence of central venous access.
  • Central venous access not positioned in the superior vena cava (e.g., femoral access).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Avicenna Military Hospital

Marrakesh, Marrakesh, 40000, Morocco

RECRUITING

Avicenna Military Hospital

Marrakesh, 40000, Morocco

RECRUITING

Department of critical care Medicine. Avicenna Military Hospital

Marrakesh, 40000, Morocco

RECRUITING

Related Publications (1)

  • Ospina-Tascon GA, Madrinan HJ. Combination of O2 and CO2-derived variables to detect tissue hypoxia in the critically ill patient. J Thorac Dis. 2019 Jul;11(Suppl 11):S1544-S1550. doi: 10.21037/jtd.2019.03.52.

MeSH Terms

Conditions

Shock, SepticSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Younes Aissaoui Pr

    Cadi Ayyad University. Faculty of Medicine and Pharmacy. Avicenna Military Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Younes Aissaoui Professor of critical care medicine

CONTACT

Ayoub Belhadj Professor of critical care medicine

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 26, 2024

First Posted

July 31, 2025

Study Start

January 5, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Biological, hemodynamic and outcome data.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
For 2 years after study completion.

Locations