Can we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study

Not Applicable

Completed

• Conditions: Chest Pain
• Interventions: Other: No Fasting prior to catheterization

• Registration Number: NCT02373527
• Lead Sponsor: The Guthrie Clinic

Brief Summary

The purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.

Detailed Description

For years it has been common to have patients fast before a cardiac catheterization. It is believed that fasting may lower the risks of upset stomach, vomiting, and aspiration (stomach contents going to the lungs). New findings show that fasting before the procedure may not be needed. This study will look at the safety and possible benefits of not fasting.

Study Timeline

• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-27
• Study Start: 2015-03-18
• Primary Completion: 2019-04-12
• Status Verified: 2019-06
• Study Completion: 2019-06-05
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 619

Inclusion Criteria

• Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients

Exclusion Criteria

• Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery
• Pregnant Women
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non Fasting	No Fasting prior to catheterization	No Fasting prior to catheterization. Usual meal on the day of the procedure and allowed to drink as usual.

Primary Outcome Measures

Name	Time	Method
Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia	72 hours

Secondary Outcome Measures

Name	Time	Method
Total cost of hospitalization	72 hours
Patient Satisfaction score	72 hours

Trial Locations

Locations (1)

Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States