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临床试验/NCT06242626
NCT06242626已完成不适用

Low T3 Versus Low T3T4 Syndrome in Septic Shock Patients- a Prospective Observational Cohort Study

Cantonal Hospital Zenica1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
1
主要终点
heart rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • septic shock patients,
  • euthyroid sick syndrome

排除标准

  • 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

结局指标

主要结局

heart rate

时间窗: 4 days

Monitoring of heart rate during the first 4 days in the ICU expressed in beats/minute

blood pressure

时间窗: 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

28-day mortality

时间窗: 28 days

28-day outcome noted as discharge from the ICU or death

次要结局

未报告次要终点

研究者

发起方
Cantonal Hospital Zenica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirza Kovacevic

Principal Investigator

Cantonal Hospital Zenica

研究点 (1)

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