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Pre-Procedural Fasting in Cardiac Intervention

NCT02562638 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-10-08

No results posted yet for this study

Summary

Traditionally, patients are kept nil-per-os (NPO) or nil-by-mouth (NBM) prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this.

The investigators aim to assess if there is a reduced incidence of vasovagal complications (primary outcome) and the combined incidence of aspiration pneumonia, change in eGFR, participant satisfaction if participants are not kept fasting.

This (pilot) randomised control trial will have an intervention arm allowing participants to drink clear liquids freely up to 1 hour before the procedure versus keeping them traditionally NPO.

240 patients will be randomised with 120 participants in each arm.

Conditions

  • Fasting

Interventions

OTHER

Non-fasting

Clear fluids up to 1hour pre-procedure and fasting for solids for up to 4 hours

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Vladimir Dzavik · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02562638 on ClinicalTrials.gov