Pre-Procedural Fasting in Cardiac Intervention

NCT02562638 | Unknown DMC

• 1 other identifier: 14-8178-A
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

NPO; NBM; pre-procedure; cardiac

Outcome Measures

Primary Outcomes (1)

• Primary: Reduction in the incidence of vasovagal complications.

  The presence of two or more of the following during the cardiac invasive procedure or during sheath removal or while manual pressure is being applied to the site will constitute a positive vasovagal reaction : i) Reduced level of consciousness, nausea and vomiting, and cold, clammy, pale skin ii) Reduction in blood pressure to \< 100mmHg systolic or \> 15% decrease from baseline iii) Reduction in the heart rate to \< 60 beats/minute (or if initial heart rate is \< 60/minute, a decrease of \> 15% from baseline). Patients' heart rate and blood pressure will be monitored (continuously) intra-procedure and (every 15 minutes) post-procedure during sheath removal and while manual pressure is being applied. The expected rate of vasovagal reaction in the NPO group is 3% .

  1 day

Secondary Outcomes (5)

• Secondary: 1. Patient satisfaction with procedure as assessed by the patient satisfaction survey form.

  1 day

• Secondary: 2. Overall incidence of aspiration pneumonia (intra and post-procedural).

  1 week post procedure

• Secondary: 3. Post-procedure change serum creatinine (∆creatinine) compared to pre-procedure.

  5 days post procedure

• Secondary: 4. Post-procedure change eGFR (∆eGFR) compared to pre-procedure.

  5 days post procedure

• Secondary: 5. Volume of gastric content immediately prior to the cardiac intervention

  1 day

Study Arms (2)

Group 1 Fasting

NO INTERVENTION

Group 1(control group) Fasting for both solids and fluids for up to 4 hours pre-procedure

Group 2 Non-fasting

EXPERIMENTAL

Group 2 (intervention arm) Clear fluids up to 1 hour before the procedure and fasting for solids up to 4 hours pre-procedure

Other: Non-fasting

Interventions

Non-fasting OTHER

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

Group 2 Non-fasting

Eligibility Criteria

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

You may qualify if:

• Ability to give written informed consent
• Diagnostic coronary angiography and coronary interventions (both elective and stable Acute Coronary Syndrome {ACS} patients).
• ≥ 18 years of age

You may not qualify if:

• Patients who are intubated
• Patients unable to give informed consent
• Patients presenting with an acute unstable condition, including:
• STEMI
• unstable ACS
• Patients with a history of or at risk for aspiration pneumonia
• stroke
• dysphagia
• severe gastroesophageal reflux disease
• Patients with known or anticipated difficult airway
• Patients who request to be allotted to a particular arm of the study
• Patients who are temporary transfers from other hospitals

Sponsors & Collaborators

• University Health Network, Toronto: lead

Related Publications (35)

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Related Links

• Sample size calculation

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Vladimir Dzavik

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Dzavik, MD,FRCPC

CONTACT

416-340-4800; vlad.dzavik@uhn.ca

Christopher B Overgaard, MD,MSc,FRCPC

CONTACT

416-340-4800; chris.overgaard@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 29, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 8, 2015

Record last verified: 2015-10