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Septic ShockNCT06242626

Euthyroid Sick Syndrome in Septic Shock

An observational study of Septic Shock, run by Cantonal Hospital Zenica at 1 site in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
What is being tested?
observation
How many people
47 participants
Where
1 siteBosnia and Herzegovina
Study dates
1 Oct 2022to 30 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • septic shock patients,
  • euthyroid sick syndrome

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site
  • Mirza Kovacevic

    Zenica, 72000

Other trials in Bosnia and Herzegovina

About this study

Official title: Low T3 Versus Low T3T4 Syndrome in Septic Shock Patients- a Prospective Observational Cohort Study

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.

Read the detailed description

This prospective observational cohort study was conducted between October 2022 and August 2023 after the institutional ethics committee's approval (N0 00-03-35-38-14/22) and patients' written consent, registered at ClinTrials.gov (NCT). Inclusion criteria were all septic shock patients with ESS with absence of previous pituitary and thyroid disease. Exclusion criteria were: age below 18, patients with previous thyroid disease or an enlarged thyroid gland, pregnant women and patients who refused to participate in the study.

Patients and study protocol Upon admission to the ICU, patients who met the criteria for septic shock according to Surviving Sepsis Campaign and the criteria for ESS were divided into two groups: group 1 - low T3 and group 2 - low T3T4.

Definitions Septic shock is defined as a consequence of sepsis, characterized by hypotension requiring the use of vasopressors to achieve mean arterial pressure (MAP) ≥65 mmHg after crystalloid resuscitation and lactate values >2 mmol/L [14].

ESS is an abnormal finding of thyroid hormones in the absence of a previous disorder of hypothalamic-pituitary and thyroid function. The most common changes are low T3, followed by low T3 and T4 with normal TSH [15]. All patients included in the study were treated according to the Sepsis Survival Campaign guidelines from 2016 [16].

Data collection Demographic data with mortality scores (APACHE II (Acute Physiology And Chronic Health Evaluation II), SAPS II (Simplified Acute Physiology Score II) and SOFA (Sequential Organ Failure Assessment) score were collected on the admission in the ICU.

Laboratory parameters were analysed on the day of admission (T0), on the first (T1) and third (T2) day of ICU stay, and included analysis of complete blood count, C-reactive protein (CRP), procalcitonin (PCT), differential blood count, acid-base status with lactates, albumins and thyroid hormones: TSH (thyroid-stimulating hormone), FT3 (free triiodothyronine), FT4 (free thyroxine). Hemodynamic monitoring included monitoring of arterial blood pressure (systolic pressure (SBP), mean pressure (MAP), diastolic pressure (DBP)) and heart rate every hour during the first 4 days. Vasoactive drug requirement were expressed through the vasoactive drug-dependent index (VDI) and the shock index (SI), and calculated as follows:

VDI: ((dobutamine dose × 1) + (norepinephrine dose × 100) + (vasopressin dose × 100) + (epinephrine dose × 100))/MAP SI: heart rate/systolic blood pressure Mechanical ventilation requirement is categorized as YES or NO, the length of ICU stay is expressed in days and 28-day survival and characterized as transfer or death.

Conditions
Septic Shock
Being tested
observation
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observationOther

    analysis of clinical, laboratory and haemodynamics parameters

Study groups in NCT06242626
Study groupRoleWhat they receive
Low T3Not described
Receives: Other: observation
Low T3T4Not described
Receives: Other: observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day mortality

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

    Measured: 28 days

  2. 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

    Measured: 4 days

  3. heart rate

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

    Measured: 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start1 Oct 2022
  3. Primary completion30 Aug 2023
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06242626
Sponsor's protocol ID
ESS2
Status last verified
Jan 2024
First submitted
28 Dec 2023
Last updated
5 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Septic Shock, run by Cantonal Hospital Zenica at 1 site in Bosnia and Herzegovina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day mortality (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.

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