跳至主要内容
临床试验/CTRI/2025/03/082468
CTRI/2025/03/082468尚未招募不适用

Correlation of High Sensitivity Troponin I with Severity of Sepsis in ICU : A Prospective Observational Study

Dr Srijan Bhattacharjee1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To correlate high sensitivity Trop I values as a predictor of sepsis severity using SOFA score.

研究概览

简要总结

Sepsis is life threatening organ dysfunction caused by a dysregulated host response as a consequence of an infection.Sepsis followed by septic shock is a leading cause of mortality in intensive care unit . Despite recent advances in the management, mortality has remained high. Myocardial dysfunction was shown to be common in patients of sepsis and septic shock. The use of cardiac biomarkers is not included in the decision making of sepsis. Cardiac dysfunction, referred to as Sepsis Induced Myocardial dysfunction (SIMD), is a loosely defined syndrome and presents in various ways , such as myocardial injury with cardiac biomarker elevation, myocardial dysfunction on echocardiography and haemodynamic instability. SIMD is a common complication (40-60%) which could possibly be result of increased circulating catecholamine and cytokine levels in severe sepsis and septic shock and its presence worsens the outcome significantly.[6] SIMD may involve either the left ventricle , right ventricle or both .This may manifest as systolic dysfunction,LV diastolic dysfunction , RV dysfunction , global hypokinesia or regional wall motion abnormalities. Early recognition , aggressive supportive therapy  and appropriate catecholamine regimen are mandatory in order to improve survival.

The Cardiac Troponin complex – consisting of troponin C, troponin T and troponin I is involved in the regulation of cardiac muscle contraction.The regulatory role of cardiac troponin I consists of inhibition of adenosine 5’-triphosphatase(ATPase) activity of the actomyosin complex and modulation of cross-bridge formation and cardiac muscle contraction.

Troponin I is exclusively of cardiac origin. It is sensitive and specific biomarker of myocardial damage and is related to prognosis in non – acute coronary syndromes such as pulmonary embolism , trauma , stroke and subarachnoid haemorrhage .  Recent studies have demonstrated that cardiac troponin release in sepsis is associated with poor outcomes , including higher mortality and longer length of stay in ICU. Theories for troponin elevation in septic shock include inflammation , increased myocardial stress by volume overload, toxicity by medications and kidney dysfunction.

New generation of  High sensitivity Troponin I assays has been recently been developed that allow the detection of concentrations 10 times lower than those measurable with conventional assays.

We will estimate the High Sensitivity Troponin I assay values occurring due to effect  of sepsis on myocardium and correlate these with SOFA score to evaluate the predictive value of this assay in outcome of sepsis.

Hypothesis Testing

Null Hypothesis : There is no correlation between HS-Troponin I values and severity of sepsis.

Alternate Hypothesis : There is positive correlation between HS-Troponin I values and severity of sepsis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with sepsis (Severe Inflammatory Response Syndrome with a proven or suspected source of infection).

排除标准

  • No informed consent given for the study.
  • Patient under coronary care(history of Coronary artery disease, Myocardial Ischaemia, coronary stent placement with or without medication).
  • Patients in immunosuppressed state (steroid treatment, Bone marrow or organ transplant patient, leukopenia, neutropenia).
  • Patients with pre-existing autoimmune conditions, have received chemotherapy/radiotherapy.
  • Return of Spontaneous circulation post cardiac arrest patients.
  • Pregnant patients.

结局指标

主要结局

To correlate high sensitivity Trop I values as a predictor of sepsis severity using SOFA score.

时间窗: Day 0,2,3 and last day of icu stay .

次要结局

  • To study the relationship of high sensitivity Trop I values with other biomarkers(- Procalcitonin)

研究者

发起方
Dr Srijan Bhattacharjee
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Srijan Bhattacharjee

Gauhati Medical College and Hospital

研究点 (1)

Loading locations...

相似试验