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CompletedNCT07745283Updated Aug 4, 2026

Vasoactive Inotropic Score in Adult Cardiac Surgery Outcomes

An observational study in Cardiac Surgical Procedures and Cardiac Surgical Procedures (Postoperative Population), sponsored by Sir Ganga Ram Hospital. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Sir Ganga Ram Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
617
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiac Surgical Procedures
  • Cardiac Surgical Procedures (Postoperative Population)

Keywords

  • Vasoactive Inotropic Score
  • Cardiac Surgery
  • Cardiopulmonary bypass
  • postoperative outcomes
  • risk stratification
03

In context

Lead sponsor

Sir Ganga Ram Hospital is the lead sponsor of 27 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
617 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Composite poor outcome

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

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

07

Study locations

1 site
  • Sir Ganga Ram Hospital
    Delhi, National Capital Territory of Delhi, India
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07745283
Lead sponsor
Sir Ganga Ram Hospital
Responsible party
Sharmil Kanna (Senior Resident, Sir Ganga Ram Hospital) — Principal investigator
First posted
Aug 4, 2026
Start date
Oct 1, 2018
Primary completion
Mar 31, 2022
Completion
Jun 30, 2022
Last update
Aug 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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