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Fasting or Non Fasting for Cardiac Catheterization

NCT03555500 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2018-06-14

No results posted yet for this study

Summary

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.

Conditions

  • Fasting
  • Cardiac Catheterization

Interventions

OTHER

Non fasting

Non fasting group is allowed for clear fluids and food up to the time of the procedure.

Sponsors & Collaborators

  • Blackpool Victoria Hospital

    lead OTHER

Principal Investigators

  • Hesham abdelaziz, Ph.D · Blackpool Victoria Hospital -UK

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2018-12-15
Completion
2019-03-10

Countries

  • United Kingdom

Study Locations

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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 NCT03555500 on ClinicalTrials.gov