跳至主要内容
临床试验/CTRI/2024/01/062110
CTRI/2024/01/062110尚未招募不适用

Study to assess the applicability of EuroSCORE II and STS score in Indian cardiac patients undergoing valve surgeries

Seth GS medical college and KEM hospital Mumbai1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
1.Discharge from hospital

研究概览

简要总结

Valvular heart disease (VHD) encompasses various structural cardiac abnormalities that disrupt normal blood flow during the cardiac cycle. In low and middle socioeconomic countries like India, rheumatic heart disease (RHD) remains a significant cause of VHD-related mortality and disability, despite a decline in global numbers. Degenerative valve disease, on the other hand, has become the most prevalent form of VHD in developed countries due to the aging population. With over one million cardiac valve surgeries performed worldwide annually, the need for objective risk scoring systems for patients undergoing these surgeries has become crucial.

Accurate risk stratification of patients undergoing cardiac valve surgeries is essential for multiple purposes, including comparing institutional practices, improving treatment decision-making, cost-benefit analysis, patient counselling, and quality improvement. The 2 models currently used worldwide for cardiac surgical patients are – Society for Thoracic Surgery (STS) and the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II). The STS risk score, which undergoes periodic updates, has proven highly effective for predicting mortality risk in cardiac surgical patients in the west and offers models for coronary artery bypass graft (CABG), isolated valve surgery, and valve surgery plus CABG. The EuroSCORE II is the recommended risk assessment model for cardiac surgeries globally. It predicts the probability of in-hospital mortality and was accepted for clinical use in 2011.

While institutions in India rely on either EuroSCORE II or the STS score for risk stratification, there is a lack of large-scale studies validating the applicability of these scoring systems in the Indian population, which typically presents with long standing disease, poor nutritional status and multiple associated comorbidities. Some studies have shown conflicting results regarding the accuracy of EuroSCORE II in predicting mortality in Indian patients, suggesting both under-prediction and over-prediction however limited data exists for the validation of the STS as well as EuroSCORE II in the Indian population.

In light of the challenges faced by tertiary cardiac centres in India, which cater to a growing number of patients with valvular heart diseases, the present study proposes a prospective observational analysis of valve surgery patients at a specific centre. The study will be conducted over a period of 1 year including a sample size of 200 patients undergoing cardiac valvular surgeries. Preoperative STS score will be calculated using https://riskcalc.sts.org/stswebriskcalc/calculate and EuroSCOREII will be calculated using calculator available on https://www.euroscore.org/index.php?Id=17. Other observations will be patient BMI, duration since first presenting symptom in the patient, aortic cross clamp time and total CPB time, VIS score for inotropic support after surgery, number of days for postoperative mechanical ventilation, need for reexploration, days to discharge from ICU and whether the patient had death or discharge from hospital.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Patients between age 18 – 60 years posted for elective isolated cardiac valvular surgeries in CVTS OT.

排除标准

  • •Patient posted for double valve replacement surgeries
  • •Patient undergoing CABG with valve surgeries
  • •Patients not willing to participate in the study
  • •Emergency valve surgeries.

结局指标

主要结局

1.Discharge from hospital

时间窗: Till 30 days of surgery

2.Death during hospital stay

时间窗: Till 30 days of surgery

次要结局

  • Dduration since first presenting symptom(Aortic cross clamp time)

研究者

发起方
Seth GS medical college and KEM hospital Mumbai
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Sanjeeta Umbarkar

Seth GS medical college and KEM hospital, MUMBAI

研究点 (1)

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