Vasoactive Inotropic Score in Adult Cardiac Surgery Outcomes

NCT07745283 | Completed

• 1 other identifier: EC/10/18/1426
• Study Type: observational
• Target: 617
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgical Procedures; Cardiac Surgical Procedures (Postoperative Population)

Keywords

Vasoactive Inotropic Score; Cardiac Surgery; Cardiopulmonary bypass; postoperative outcomes; risk stratification

Outcome Measures

Primary Outcomes (1)

• Composite poor outcome

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Ganga Ram Hospital

Delhi, National Capital Territory of Delhi, India

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: October 1, 2018
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)