NCT03555500: FANPRECC

Fasting or Non Fasting for Cardiac Catheterization

Status unknown NA Last updated 14 June 2018

What this trial tests

NA trial testing Non fasting in Fasting in 350 participants. Status unknown.

Timeline

2 November 2017

Primary endpoint
15 December 2018

10 March 2019

Quick facts

Lead sponsor	Blackpool Victoria Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	350
Start date	2 November 2017
Primary completion	15 December 2018
Estimated completion	10 March 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Non fasting

Conditions studied

• Fasting — all drugs for Fasting →
• Cardiac Catheterization — all drugs for Cardiac Catheterization →

Sponsor

Blackpool Victoria Hospital

Who can join

18 and older, any sex, with Fasting or Cardiac Catheterization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The current practice of fasting before cardiac catheterization is not based on any studies. If the procedure is to be delayed ( which is common due to busy catheterization lab), this could result in patient's dis-satisfaction and hypoglycemia. Occasionally, cancellation occur because patients are found to be non fasting ( not following the current protocol). The old data of fasting was extrapolated from procedure done under general anesthesia. Now days, cardiac catheterization is always done under local anesthesia and mild sedation. As a matter of fact, emergency cardiac catheterization done for heart attack patients carries more risk than elective one , and are still done without fasting with no reported complication rate like lung aspiration . The highest level of evidence to change the current practice comes from randomized control study. This study has been designed to challenge the current practice. The patients will be divided into 2 groups:

* Fasting group (current practice): Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure.
* Non Fasting Group: clear fluids and food and up to the time of the procedure

The investigators' aim is to show that there is no difference with regards to potential complications between fasting (current practice) and non fasting (new practice) groups of patients with less incidence of hypoglycemia and hypotension in non fasting group. In addition, The investigators believe that patient satisfaction will be improved if patients are allowed to eat freely before the procedure and the catheter lab working ability will be maximized as the list can be filled promptly with patient on the waiting list (as fasting is no longer required) if a previously booked patient has to be cancelled in the last minute improving patient experience along with the associated financial benefits.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.