Vasoactive Inotropic Score in Adult Cardiac Surgery Outcomes

July 29, 2026 updated by: Sharmil Kanna, Sir Ganga Ram Hospital

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

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

617

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • National Capital Territory of Delhi
      • Delhi, National Capital Territory of Delhi, India
        • Sir Ganga Ram Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing elective or semi-elective cardiac surgery requiring cardiopulmonary bypass at a single tertiary cardiac surgical centre in New Delhi, India, including valve surgery, coronary artery bypass grafting, combined procedures, and aortic surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adult cardiac surgery patients undergoing CPB
All patients undergoing elective or semi-elective cardiac surgery with cardiopulmonary bypass (CPB), including valve surgery, coronary artery bypass grafting, combined procedures, and aortic surgery. Vasoactive Inotropic Score (VIS) was recorded at 5 postoperative timepoints (on shifting to the cardiac recovery unit, and at 6, 12, 24, and 48 hours) based on doses of vasoactive and inotropic medications administered per routine clinical care. No intervention was assigned by the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From surgery until hospital discharge, or up to 30 days post-discharge for death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

July 29, 2026

First Submitted That Met QC Criteria

July 29, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not being made publicly available at this time. De-identified data may be made available from the corresponding author on reasonable request, subject to institutional approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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