Cardiac Surgical ProceduresNCT07745283
Vasoactive Inotropic Score in Adult Cardiac Surgery Outcomes
An observational study of Cardiac Surgical Procedures and Cardiac Surgical Procedures (Postoperative Population), run by Sir Ganga Ram Hospital at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Cardiac Surgical Procedures (Postoperative Population)
- How many people
- 635 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2018to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing 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.
Who may be able to join
- Age 18 years or older
- Undergoing cardiac surgery with cardiopulmonary bypass (CPB)
Who cannot join
- Required CPB solely for extracorporeal membrane oxygenation (ECMO)
- Pre-operative mechanical circulatory support in situ (ECMO, VAD, IABP)
- Declined to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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 599 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 599 adults undergoing 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), central nervous system injury or life threatening arrhythmias (VT/VF). 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.
This study evaluated serial (multi-timepoint) VIS measurement, rather than a single measurement, as a predictor of postoperative outcome in a heterogeneous adult cardiac surgical population.
- Keywords
- Vasoactive Inotropic Score, Cardiac Surgery, Cardiopulmonary bypass, postoperative outcomes, risk stratification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult cardiac surgery patients undergoing CPB | All patients undergoing 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 being measured
The primary outcome is the main question the study is designed to answer.
Composite poor outcome
death, cardiac arrest, mechanical circulatory support, acute kidney injury, or central nervous system injury, life threatening arrythmias (VT/VF)
Measured: From surgery until hospital discharge, or up to 30 days post-discharge for death
Secondary outcomes (3)
ICU length of stay
Days from postoperative intensive care unit admission to intensive care unit discharge
Measured: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 90 days after surgery.
Time to first extubation
Hours from postoperative intensive care unit admission to first removal of the endotracheal tube.
Measured: From postoperative intensive care unit admission until first extubation, assessed up to 90 days after surgery.
Hospital length of stay
Days from hospital admission to hospital discharge.
Measured: From hospital admission until hospital discharge, assessed up to 90 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Oct 2018
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharmil Kanna, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745283
- Sponsor's protocol ID
- EC/10/18/1426
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07745283
- Acronym / sponsor ID
- EC/10/18/1426
- Keywords
- Vasoactive Inotropic Score, Cardiac Surgery, Cardiopulmonary bypass, postoperative outcomes, risk stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 599 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.
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 599 adults undergoing 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), central nervous system injury or life threatening arrhythmias (VT/VF). 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.
This study evaluated serial (multi-timepoint) VIS measurement, rather than a single measurement, as a predictor of postoperative outcome in a heterogeneous adult cardiac surgical population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult cardiac surgery patients undergoing CPB | – | –All patients undergoing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing 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.
Key inclusion criteria (2 listed)
- Age 18 years or older
- Undergoing cardiac surgery with cardiopulmonary bypass (CPB)
Key exclusion criteria (3 listed)
- Required CPB solely for extracorporeal membrane oxygenation (ECMO)
- Pre-operative mechanical circulatory support in situ (ECMO, VAD, IABP)
- Declined to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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, life threatening arrythmias (VT/VF)
3 secondary outcomes
ICU length of stay
Time frame: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 90 days after surgery.
Time to first extubation
Time frame: From postoperative intensive care unit admission until first extubation, assessed up to 90 days after surgery.
Hospital length of stay
Time frame: From hospital admission until hospital discharge, assessed up to 90 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedures and Cardiac Surgical Procedures (Postoperative Population), run by Sir Ganga Ram Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite poor outcome (time frame: From surgery until hospital discharge, or up to 30 days post-discharge for death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.