Euthyroid Sick SyndromesPhase 2NCT05270798
Thyroid Hormone Supplementation in Patients With Septic Shock
A Phase 2 study testing triiodothyronine in people with Euthyroid Sick Syndromes and Septic Shock, run by Cantonal Hospital Zenica at 1 site in Bosnia and Herzegovina.
Trial summary
The primary aim of the study would be to determine whether there is a difference in survival in the Intensive Care Unit between the group of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients not treated with this hormone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Euthyroid Sick Syndromes, Septic Shock
- What is being tested?
- triiodothyronine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 May 2022to 1 Aug 2023
- Phase
- Phase 2
- 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
Who may be able to join
- all patients who meet the criteria for septic shock according to the definition of Surviving sepsis campaigning (The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016): persistent hypotension requiring the use of vasoactive drugs to maintain mean arterial pressure ≥65 mm Hg ; blood lactates> 2 mmol / L despite adequate resuscitation volume,
- patients with laboratory-proven euthyroid sick syndrome, according to diagnostic criteria which include: normal levels of TSH hormone, low levels of T3 hormone that may accompany low levels of T4 hormone (depending on the stage of critical disease) and absence of previous primary thyroid and pituitary disease.
Who cannot join
- age below 18,
- patients with a history of thyroid disease or an enlarged thyroid gland,
- psychiatric patients,
- patients on hormone therapy (excluding insulin),
- those taking amiodarone, corticosteroids or dopamine
- pregnant or postpartum mothers 6 months ago,
- patients who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triiodothyronine Hormone Supplementation Therapy in Patients With Septic Shock With Euthyroid Sick Syndrome
The primary aim of the study would be to determine whether there is a difference in survival in the Intensive Care Unit between the group of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients not treated with this hormone. Secondary objectives of the research would be:
Compare the level of thyroid hormones between the examined groups and
- laboratory indicators of septic shock (C-reactive protein-CRP, procalcitonin, leukocytes, acid-base status, lactates)
- APACHE II, SOFA and SAPS II patient assessment scales,
- inflammatory prognostic systems (ratio of CRP and albumin-modified Glasgow prognostic score-mGPS, ratio of neutrophils and lymphocytes - NLR, ratio of platelets and lymphocytes - PLR, and ratio of leukocytes and CRP, prognostic index - PI)
- hemodynamic stability of patients (MAP, systolic and diastolic pressure) in the periods of admission T0, T3, T6, T12, T24 and every 24 hours for 4 days,
- effect of vasoactive drugs,
- the need for mechanical ventilation categorized as yes or no, in case - number of respirator days,
- length of stay in the Intensive Care Unit,
- treatment outcome categorized as 28 day survival.
- Conditions
- Euthyroid Sick Syndromes, Septic Shock
- Being tested
- triiodothyronine
- Keywords
- septic shock, euthyroid sick syndrome, triiodothyronine
- Medical subject headings
- Euthyroid Sick Syndromes, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triiodothyronineDrug
Patients in septic shock who meet the diagnostic criteria for euthyroid sick syndrome will be divided into two groups; patients with low T3 levels and patients with low T3 and T4 levels. Both of these groups will be further randomly divided into patients receiving T3 hormone and patients receiving placebo.
| Study group | Role | What they receive |
|---|---|---|
| Patients with low triiodothyronine levels who received triiodothyronine | Experimental | Not described Receives: Drug: triiodothyronine |
| Patients with low triiodothyronine levels who received placebo | Placebo comparator | Not described Receives: Drug: triiodothyronine |
| Patients with low triiodothyronine and low tetraiodothyronine levels who received triiodothyronine | Experimental | Not described Receives: Drug: triiodothyronine |
| Patients with low triiodothyronine and low tetraiodothyronine levels who received placebo | Placebo comparator | Not described Receives: Drug: triiodothyronine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in survival in the Intensive Care Unit between the groups of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients who were not treated with this hormone.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 May 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Euthyroid Sick SyndromesStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 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
- NCT05270798
- Sponsor's protocol ID
- ESS
- Status last verified
- Sep 2023
- First submitted
- 26 Feb 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kovacevic M, Adam VN, Causevic S. Triiodothyronine hormone supplementation therapy in septic shock patients with euthyroid sick syndrome: two pilot, placebo-controlled, randomized trials. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101336. doi: 10.1016/j.accpm.2023.101336. Epub 2023 Dec 5.
PubMed 38061681
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triiodothyronine Hormone Supplementation Therapy in Patients With Septic Shock With Euthyroid Sick Syndrome
- ClinicalTrials.gov ID
- NCT05270798
- Acronym / sponsor ID
- ESS
- Conditions
- Euthyroid Sick Syndromes, Septic Shock
- Keywords
- septic shock, euthyroid sick syndrome, triiodothyronine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Cantonal Hospital ZenicaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 8 Mar 2022 (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.
The primary aim of the study would be to determine whether there is a difference in survival in the Intensive Care Unit between the group of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients not treated with this hormone. Secondary objectives of the research would be:
Compare the level of thyroid hormones between the examined groups and
- laboratory indicators of septic shock (C-reactive protein-CRP, procalcitonin, leukocytes, acid-base status, lactates)
- APACHE II, SOFA and SAPS II patient assessment scales,
- inflammatory prognostic systems (ratio of CRP and albumin-modified Glasgow prognostic score-mGPS, ratio of neutrophils and lymphocytes - NLR, ratio of platelets and lymphocytes - PLR, and ratio of leukocytes and CRP, prognostic index - PI)
- hemodynamic stability of patients (MAP, systolic and diastolic pressure) in the periods of admission T0, T3, T6, T12, T24 and every 24 hours for 4 days,
- effect of vasoactive drugs,
- the need for mechanical ventilation categorized as yes or no, in case - number of respirator days,
- length of stay in the Intensive Care Unit,
- treatment outcome categorized as 28 day survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with low triiodothyronine levels who received triiodothyronine | Experimental | Drug: triiodothyronine |
| Patients with low triiodothyronine levels who received placebo | Placebo comparator | Drug: triiodothyronine |
| Patients with low triiodothyronine and low tetraiodothyronine levels who received triiodothyronine | Experimental | Drug: triiodothyronine |
| Patients with low triiodothyronine and low tetraiodothyronine levels who received placebo | Placebo comparator | Drug: triiodothyronine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients who meet the criteria for septic shock according to the definition of Surviving sepsis campaigning (The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016): persistent hypotension requiring the use of vasoactive drugs to maintain mean arterial pressure ≥65 mm Hg ; blood lactates> 2 mmol / L despite adequate resuscitation volume,
- patients with laboratory-proven euthyroid sick syndrome, according to diagnostic criteria which include: normal levels of TSH hormone, low levels of T3 hormone that may accompany low levels of T4 hormone (depending on the stage of critical disease) and absence of previous primary thyroid and pituitary disease.
Key exclusion criteria (7 listed)
- age below 18,
- patients with a history of thyroid disease or an enlarged thyroid gland,
- psychiatric patients,
- patients on hormone therapy (excluding insulin),
- those taking amiodarone, corticosteroids or dopamine
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 |
|---|---|---|
| triiodothyroninePatients in septic shock who meet the diagnostic criteria for euthyroid sick syndrome will be divided into two groups; patients with low T3 levels and patients with low T3 and T4 levels. Both of these groups will be further randomly divided into patients receiving T3 hormone and patients receiving placebo. | Drug | Patients with low triiodothyronine and low tetraiodothyronine levels who received placebo, Patients with low triiodothyronine and low tetraiodothyronine levels who received triiodothyronine, Patients with low triiodothyronine levels who received placebo, Patients with low triiodothyronine levels who received triiodothyronine |
Primary outcome
The difference in survival in the Intensive Care Unit between the groups of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients who were not treated with this hormone.
Time frame: 28 days
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 28 Sep 2023.
- Derived from this study: PubMed 38061681Kovacevic M, Adam VN, Causevic S. Triiodothyronine hormone supplementation therapy in septic shock patients with euthyroid sick syndrome: two pilot, placebo-controlled, randomized trials. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101336. doi: 10.1016/j.accpm.2023.101336. Epub 2023 Dec 5.
- Individual participant dataSharing planned: Yes
Related trials for Euthyroid Sick Syndromes
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
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?
A Phase 2 study testing triiodothyronine in people with Euthyroid Sick Syndromes and 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 7 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 28 Sep 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The difference in survival in the Intensive Care Unit between the groups of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients who were not treated with this hormone. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270798, which also lists 1 linked publication.
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 28 Sep 2023; AzTrials last refreshed its copy on 1 Nov 2026.