Pre-Procedural Fasting in Cardiac Intervention
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
Clear fluids up to 1hour pre-procedure and fasting for solids for up to 4 hours
- 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: 1. Patient satisfaction with procedure as assessed by the patient satisfaction survey form. [ Time Frame: 1 day ]
- Secondary: 2. Overall incidence of aspiration pneumonia (intra and post-procedural). [ Time Frame: 1 week post procedure ]
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562638
|Contact: Vladimir Dzavik, MD,FRCPC||416-340-4800 ext email@example.com|
|Contact: Christopher B Overgaard, MD,MSc,FRCPC||416-340-4800 ext firstname.lastname@example.org|
|Principal Investigator:||Vladimir Dzavik||University Health Network, Toronto|