NCT07245550

Brief Summary

A dysregulated host response to infection results in organ failure and sepsis, a potentially fatal illness. Sepsis killed about 11 million people worldwide in 2017 and had a death rate close to 20 %

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Dec 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

September 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

September 26, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

septic shock

Outcome Measures

Primary Outcomes (1)

  • serum Thyroid and adrenal hormones levels

    measurement of thyroid and adrenal hormones (TSH-FT3-FT4 - cortisol level ) will be measured by ELLISA technique in septic shock patients at ICU.

    24 hours

Study Arms (1)

Patients with septic shock in the ICU

Blood sampling for thyroid and adrenal hormones

Diagnostic Test: Blood sampling

Interventions

Blood samplingDIAGNOSTIC_TEST

Blood sampling for the hormones

Patients with septic shock in the ICU

Eligibility Criteria

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

Patients with septic shock admitted at intensive care unit and their age is above 18 years old

You may qualify if:

  • All Patients who match the diagnostic criteria for sepsis/septic shock as stated
  • admitted in ICU

You may not qualify if:

  • Patients refuse to be enrolled in the study
  • Patients with previous endocrinal disorders.
  • Patients receiving corticosteroid or thyroid hormonal therapy.
  • Pregnancy or lactation.
  • Previous endocrinal gland surgery.
  • Individuals with pacing rhythms, bundle branch blocks (QRS interval \>120 ms),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radwa mahmoud

Asyut, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Radwa m elsayed, MB

    assuit university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Radwa M Elsayed, MB

CONTACT

Mohamed F Adawy, MB

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 26, 2025

First Posted

November 24, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations