跳至主要内容
临床试验/CTRI/2025/11/097145
CTRI/2025/11/097145尚未招募不适用

Relationship between the dynamic trajectory of biomarkers for bleeding, thrombosis and infection in patients on veno-arterial extracorporeal membrane oxygenation and their causal association with ICU mortality

Journal of Cardiac Critical Care The Simulation Society Research fund1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月21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
100
试验地点
1
主要终点
Mortality on VA-ECMO in ICU and its correlation to the levels of various biomarker levels.

研究概览

简要总结

Venoarterial ECMO (VA-ECMO) is a subset in which both mechanical circulatory support as well as gas exchange functions are taken over by the ECMO machine to provide a bridge for patients in severe cardiorespiratory failure. However, it is not without complications. The three most common and fatal complications encountered in ECMO patients are- Bleeding, thrombosis and infection. Hence, to monitor the progress of patients on ECMO we need to assess for these complications from time to time which can be done by monitoring the levels of various biomarkers. Certain tests are routinely performed at our institute to monitor ECMO patients. However, till now no research is available to show the utility of point-of-care biomarker tests for bleeding, thrombosis and infection and how the results of these can be correlated with each other and also to predict the outcome of patients on ECMO. Most of the data available till now is from retrospective, observational studies with very little literature available from Indian population. Most studies also focus on a single outcome measure and do not study the correlation among various biomarkers for bleeding/thrombosis/infection and their causal association with mortality. Thus, we wish to undertake this research to study the correlation between biomarkers for bleeding, thrombosis and infection in patients on VA-ECMO post cardiac surgery in the ICU and their causal association with the final outcome of the patients in ICU. Also, we wish to develop an AIIMS scoring for 5 best biomarkers for prognostic screening in VA-ECMO patients.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients from age birth till 50 years Either gender Undergoing elective cardiac surgery on cardiopulmonary bypass requiring integrated VA ECMO.

排除标准

  • Emergency cardiac surgeries or Re-do surgeries ECMO duration less than 24h Pre-existing coagulopathies Pre-existing liver or kidney or neurological dysfunction Pre-existing systemic infection Errors in detection of biomarkers or incomplete detection of biomarkers needed for analysis Lack of consent from the patient.

结局指标

主要结局

Mortality on VA-ECMO in ICU and its correlation to the levels of various biomarker levels.

时间窗: Samples will be collected at baseline followed by 24h followed by 72h and at 7 days after ECMO initiation depending on the survival

次要结局

  • Drain output in first 24 hours in ICU(at first 24h)
  • Blood transfusion requirement on ECMO in ICU(Total blood and blood product transfusion from beginning till weaning or mortality on ECMO)
  • Duration of mechanical ventilation in ICU(From initiation of ECMO till weaning from mechanical ventilation)
  • Antibiotic requirement and incidence of sepsis(From ECMO initiation till weaning from ECMO)
  • Vasoactive Inotropic Score(Calculated at baseline followed by 24h followed by 72h and at 7 days after ECMO initiation depending on the survival)
  • Correlation between biomarkers for bleeding, thrombosis and infection.(Samples will be collected at baseline followed by 24h followed by 72h and at 7 days after ECMO initiation depending on the survival)

研究者

发起方
Journal of Cardiac Critical Care The Simulation Society Research fund
申办方类型
Other [Journal of Cardiac Critical Care – The Simulation Society Research fund ]
责任方
Principal Investigator
主要研究者

Dr Khushboo Mehta

All India Institute of Medical Sciences New Delhii

研究点 (1)

Loading locations...

相似试验