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

Strict Versus No Fasting Prior to Cardiac Catheterization: A Prospective Evaluation of Safety and Clinical Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Other: No Fasting prior to catheterization

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 Type: Interventional
• Enrollment (Actual): 619
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard - Strict Fasting; No food after midnight the night before the procedure and will be allowed to drink clear liquids up to 2 hours prior to the procedure.
Experimental: Non Fasting; No Fasting prior to catheterization. Usual meal on the day of the procedure and allowed to drink as usual.	Other: No Fasting prior to catheterization; No restriction for oral intake

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Satisfaction score	72 hours
Total cost of hospitalization	72 hours

Collaborators and Investigators

• Sponsor: The Guthrie Clinic
• Investigators: Principal Investigator: Daniel Sporn, MD, The Guthrie Clinic; Principal Investigator: Abhishek Mishra, MD, The Guthrie Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2015
• Primary Completion (Actual): April 12, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: 1411-60

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No