- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07745283
Vasoactive Inotropic Score in Adult Cardiac Surgery Outcomes
Serial Vasoactive Inotropic Score as a Predictor of Postoperative Outcomes in Adult Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Prospective Observational Cohort Study
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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National Capital Territory of Delhi
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Delhi, National Capital Territory of Delhi, India
- Sir Ganga Ram Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Composite poor outcome
Time Frame: From surgery until hospital discharge, or up to 30 days post-discharge for death
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death, cardiac arrest, mechanical circulatory support, acute kidney injury, or central nervous system injury
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From surgery until hospital discharge, or up to 30 days post-discharge for death
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EC/10/18/1426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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