Triiodothyronine Hormone Supplementation Therapy in Patients With Septic Shock With Euthyroid Sick Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients with low triiodothyronine levels who received triiodothyronine
干预措施: triiodothyronine (Drug)
Patients with low triiodothyronine levels who received placebo
干预措施: triiodothyronine (Drug)
Patients with low triiodothyronine and low tetraiodothyronine levels who received triiodothyronine
干预措施: triiodothyronine (Drug)
Patients with low triiodothyronine and low tetraiodothyronine levels who received placebo
干预措施: triiodothyronine (Drug)
结局指标
主要结局
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.
时间窗: 28 days
次要结局
未报告次要终点
研究者
Mirza Kovacevic
Anesthesiologist
Cantonal Hospital Zenica
