Thyroid Hormone Supplementation in Patients With Septic Shock
Primary Purpose
Euthyroid Sick Syndromes, Septic Shock
Status
Completed
Phase
Phase 2
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
triiodothyronine
Sponsored by
About this trial
This is an interventional treatment trial for Euthyroid Sick Syndromes focused on measuring septic shock, euthyroid sick syndrome, triiodothyronine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Cantonal Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Patients with low triiodothyronine levels who received triiodothyronine
Patients with low triiodothyronine levels who received placebo
Patients with low triiodothyronine and low tetraiodothyronine levels who received triiodothyronine
Patients with low triiodothyronine and low tetraiodothyronine levels who received placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05270798
First Posted
February 26, 2022
Last Updated
September 27, 2023
Sponsor
Cantonal Hospital Zenica
1. Study Identification
Unique Protocol Identification Number
NCT05270798
Brief Title
Thyroid Hormone Supplementation in Patients With Septic Shock
Official Title
Triiodothyronine Hormone Supplementation Therapy in Patients With Septic Shock With Euthyroid Sick Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital Zenica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Euthyroid Sick Syndromes, Septic Shock
Keywords
septic shock, euthyroid sick syndrome, triiodothyronine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with low triiodothyronine levels who received triiodothyronine
Arm Type
Experimental
Arm Title
Patients with low triiodothyronine levels who received placebo
Arm Type
Placebo Comparator
Arm Title
Patients with low triiodothyronine and low tetraiodothyronine levels who received triiodothyronine
Arm Type
Experimental
Arm Title
Patients with low triiodothyronine and low tetraiodothyronine levels who received placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
triiodothyronine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Cantonal Hospital
City
Zenica
ZIP/Postal Code
72000
Country
Bosnia and Herzegovina
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Thyroid Hormone Supplementation in Patients With Septic Shock
We'll reach out to this number within 24 hrs