NCT06256198

Brief Summary

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, if not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death. Sepsis is associated with high mortality, and the early recognition of the signs of tissue hypo perfusion is crucial in its management. This prospective study was aimed to detect that PCO2 gap can be taken as a reliable prognostic tool in septic patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

January 31, 2024

Last Update Submit

February 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • prediction of clinical outcome in ICU septic patients

    PCO2 gap mmHg will be measured on admission and after 48 hours

    48 hours

Study Arms (2)

Group S

survivors

Other: measurement of serum lactate and procalcitonin and PCO2 gap

Group M

non survivors

Other: measurement of serum lactate and procalcitonin and PCO2 gap

Interventions

measurement of serum lactate, procalcitonin and PCO2 gap

Group MGroup S

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted in ICU departments with sepsis

You may qualify if:

  • Adult septic patients ≥ 21 years old

You may not qualify if:

  • Patients with history of chronic obstructive pulmonary disease and bronchial asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CalcitoninPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProtein PrecursorsProteins

Central Study Contacts

Ahmed El-Dolah, lecturer of Anesthesia

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 13, 2024

Study Start

February 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02