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.
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.
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 group | Role | What they receive |
|---|---|---|
| Low T3 | Not described Receives: Other: observation | |
| Low T3T4 | Not described Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
28-day outcome noted as discharge from the ICU or death
Measured: 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
Measured: 4 days
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.
- First posted5 Feb 2024
- Study start1 Oct 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital Zenica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirza Kovacevic, Cantonal Hospital Zenica
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low T3 Versus Low T3T4 Syndrome in Septic Shock Patients- a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06242626
- Acronym / sponsor ID
- ESS2
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Cantonal Hospital ZenicaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low T3 | – | Other: observation |
| Low T3T4 | – | Other: observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- septic shock patients,
- euthyroid sick syndrome
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationanalysis of clinical, laboratory and haemodynamics parameters | Other | Low T3, Low T3T4 |
Primary outcome
28-day mortality
Time frame: 28 days
28-day outcome noted as discharge from the ICU or death
blood pressure
Time frame: 4 days
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
heart rate
Time frame: 4 days
Monitoring of heart rate during the first 4 days in the ICU expressed in beats/minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.