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OpenTrials
Completed

NCT Number: NCT07745283

Vasoactive Inotropic Score in Adult Cardiac Surgery Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sir Ganga Ram Hospital

Delhi, National Capital Territory of Delhi, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Composite poor outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sir Ganga Ram Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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