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Pre-Procedural Fasting in Cardiac Intervention

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ClinicalTrials.gov Identifier: NCT02562638
Recruitment Status : Unknown
Verified October 2015 by University Health Network, Toronto.
Recruitment status was:  Not yet recruiting
First Posted : September 29, 2015
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Fasting Other: Non-fasting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Do Patients Need Pre-Procedural Fasting for Coronary Artery Procedures?
Study Start Date : October 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
No Intervention: Group 1 Fasting
Group 1(control group) Fasting for both solids and fluids for up to 4 hours pre-procedure
Experimental: Group 2 Non-fasting
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
Clear fluids up to 1hour pre-procedure and fasting for solids for up to 4 hours




Primary Outcome Measures :
  1. Primary: Reduction in the incidence of vasovagal complications. [ Time Frame: 1 day ]

    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% .



Secondary Outcome Measures :
  1. Secondary: 1. Patient satisfaction with procedure as assessed by the patient satisfaction survey form. [ Time Frame: 1 day ]
  2. Secondary: 2. Overall incidence of aspiration pneumonia (intra and post-procedural). [ Time Frame: 1 week post procedure ]
  3. Secondary: 3. Post-procedure change serum creatinine (∆creatinine) compared to pre-procedure. [ Time Frame: 5 days post procedure ]
    The difference between a single pre-procedure measurement of serum creatinine and a single post procedure measure of serum creatinine will be calculated as ∆creatinine. The average ∆creatinine in each randomised arm will be compared to assess difference if any.

  4. Secondary: 4. Post-procedure change eGFR (∆eGFR) compared to pre-procedure. [ Time Frame: 5 days post procedure ]
    The difference between a single pre-procedure measurement of eGFR and a single post procedure measure of eGFR will be calculated as ∆eGFR. The average ∆eGFR in each randomised arm will be compared to assess difference if any.

  5. Secondary: 5. Volume of gastric content immediately prior to the cardiac intervention [ Time Frame: 1 day ]
    This will be assessed in a random subset of 60 patients (30 from each Group) by bedside sonography. Using standard portable ultrasound equipment, a bedside gastric examination will be performed by an investigator blinded to group allocation, in a standard manner as previously described . The volume will be measured in millilitres (ml).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to give written informed consent
  2. Diagnostic coronary angiography and coronary interventions (both elective and stable Acute Coronary Syndrome {ACS} patients).
  3. ≥ 18 years of age

Exclusion Criteria:

  1. Patients who are intubated
  2. Patients unable to give informed consent
  3. Patients presenting with an acute unstable condition, including:

    1. STEMI
    2. unstable ACS
  4. Patients with a history of or at risk for aspiration pneumonia

    • stroke
    • dysphagia
    • severe gastroesophageal reflux disease
  5. Patients with known or anticipated difficult airway
  6. Patients who request to be allotted to a particular arm of the study
  7. Patients who are temporary transfers from other hospitals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562638


Contacts
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Contact: Vladimir Dzavik, MD,FRCPC 416-340-4800 ext 6265 vlad.dzavik@uhn.ca
Contact: Christopher B Overgaard, MD,MSc,FRCPC 416-340-4800 ext 6265 chris.overgaard@uhn.ca

Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Vladimir Dzavik University Health Network, Toronto
Additional Information:
Publications:
Rosengarten J, Ozkor M, Knight C: Fasting and cardiac catheterization should we be following the evidence; Controversies and consensus in imaging and intervention (C2I2) 2007: V (2); 22-23
Chan KLL. Etomidate and midazolam for procedural sedation in the emergency department of Queen Elizabeth Hospital: a randomised controlled trial. Hong Kong J Emerg Med 2008; 15: 75-87.
S. B. Hulley, S. R. Cummings, W. S. Browner, et al: Designing Clinical Research: Fourth Edition, LWW, 2013.

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02562638    
Other Study ID Numbers: 14-8178-A
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Keywords provided by University Health Network, Toronto:
NPO
NBM
pre-procedure
cardiac