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临床试验/NCT07745283
NCT07745283已完成不适用

Serial Vasoactive Inotropic Score as a Predictor of Postoperative Outcomes in Adult Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Prospective Observational Cohort Study

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 617 人开始时间: 2018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
入组人数
617
试验地点
1
主要终点
Composite poor outcome

研究概览

简要总结

This study looked at whether a bedside score called the Vasoactive Inotropic Score (VIS) could help doctors predict which adult patients are at higher risk of complications after heart surgery that uses a heart-lung machine (cardiopulmonary bypass). VIS is calculated from the doses of heart-support medications a patient is already receiving after surgery, so it does not require any extra tests or procedures. Researchers measured VIS at five points in the first two days after surgery in 232 adults undergoing a range of heart operations, including valve surgery and coronary artery bypass. The study found that VIS measured soon after surgery, and again at 24 hours, gave useful early warning of which patients were more likely to experience serious complications such as kidney injury, stroke, or the need for additional circulatory support. This information could help hospital teams identify at-risk patients earlier and monitor them more closely.

详细描述

Serial Vasoactive Inotropic Score (VIS) was recorded prospectively at 5 postoperative timepoints (on shifting to the cardiac recovery unit, and at 6, 12, 24, and 48 hours) in 232 adults undergoing elective or semi-elective cardiac surgery with cardiopulmonary bypass at a single tertiary centre. The primary outcome was a composite of death, cardiac arrest, mechanical circulatory support, acute kidney injury (RIFLE criteria), or central nervous system injury. Secondary outcomes were ICU length of stay, hospital length of stay, and time to first extubation.

Receiver operating characteristic (ROC) analysis, multivariate logistic regression, and Spearman rank correlation were used to evaluate the predictive performance of VIS at each timepoint, both independently and adjusted for EuroSCORE II, cardiopulmonary bypass time, aortic cross-clamp time, age, and pre-operative ejection fraction. A pre-specified sensitivity analysis incorporating low cardiac output syndrome into the primary composite outcome was also performed.

This study is the first to evaluate serial (multi-timepoint) VIS measurement, rather than a single measurement, as a predictor of postoperative outcome in a heterogeneous adult cardiac surgical population.

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

  • Age 18 years or older
  • Undergoing elective or semi-elective cardiac surgery with cardiopulmonary bypass (CPB)

排除标准

  • Required CPB solely for extracorporeal membrane oxygenation (ECMO)
  • Pre-operative left ventricular assist device (LVAD) in situ
  • Pre-operative intra-aortic balloon pump (IABP) support
  • Declined to provide consent

结局指标

主要结局

Composite poor outcome

时间窗: From surgery until hospital discharge, or up to 30 days post-discharge for death

death, cardiac arrest, mechanical circulatory support, acute kidney injury, or central nervous system injury

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharmil Kanna

Senior Resident

Sir Ganga Ram Hospital

研究点 (1)

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