Thyroid Hormone Supplementation in Patients With Septic Shock

NCT05270798 | Completed Phase 2 DMC

• 1 other identifier: ESS
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. Secondary objectives of the research would be: Compare the level of thyroid hormones between the examined groups and

1. 1.laboratory indicators of septic shock (C-reactive protein-CRP, procalcitonin, leukocytes, acid-base status, lactates)
2. 2.APACHE II, SOFA and SAPS II patient assessment scales,
3. 3.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)
4. 4.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,
5. 5.effect of vasoactive drugs,
6. 6.the need for mechanical ventilation categorized as yes or no, in case - number of respirator days,
7. 7.length of stay in the Intensive Care Unit,
8. 8.treatment outcome categorized as 28 day survival.

Conditions

Euthyroid Sick Syndromes; Septic Shock

Keywords

septic shock; euthyroid sick syndrome; triiodothyronine

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Study Arms (4)

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

Interventions

triiodothyronine DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cantonal Hospital Zenica: lead

Study Sites (1)

Cantonal Hospital

Zenica, 72000, Bosnia and Herzegovina

Location

Related Publications (1)

• 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.

  PMID: 38061681 DERIVED

MeSH Terms

Conditions

Euthyroid Sick Syndromes; Shock, Septic

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 8, 2022
• Study Start: May 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

BO (1)