NCT06242626

Brief Summary

This prospective observational cohort study included all septic shock patients with two groups of ESS and anylised in 28-day outcome, clinical biochemical parameters and hemodynamic monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

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

October 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

December 28, 2023

Last Update Submit

January 29, 2024

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (3)

  • 28-day mortality

    28-day outcome noted as discharge from the ICU or death

    28 days

  • blood pressure

    Monitoring of arterial blood pressure (systolic pressure (SBP), mean pressure (MAP), diastolic pressure (DBP)) during the first 4 days in the ICU expressed in mmHg

    4 days

  • heart rate

    Monitoring of heart rate during the first 4 days in the ICU expressed in beats/minute

    4 days

Study Arms (2)

Low T3

Other: observation

Low T3T4

Other: observation

Interventions

observationOTHER

analysis of clinical, laboratory and haemodynamics parameters

Low T3Low T3T4

Eligibility Criteria

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

Forty seven patients who met criteria for septic shock according to new definitions according to Surviving Sepsis Campaign and criteria for euthyroid sick syndrome were divided into two groups: group 1 - low T3 and group 2 - low T3T4

You may qualify if:

  • septic shock patients,
  • euthyroid sick syndrome

You may not qualify if:

  • age below 18,
  • patients with previous thyroid disease or an enlarged thyroid gland,
  • psychiatric patients,
  • pregnant women or women who gave birth in the past 6 months and
  • patients who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirza Kovacevic

Zenica, 72000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Observation

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

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

December 28, 2023

First Posted

February 5, 2024

Study Start

October 1, 2022

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

BO(1)