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

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ClinicalTrials.gov Identifier: NCT02373527
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chest Pain Other: No Fasting prior to catheterization Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Strict Versus No Fasting Prior to Cardiac Catheterization: A Prospective Evaluation of Safety and Clinical Outcomes
Actual Study Start Date : March 18, 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

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




Primary Outcome Measures :
  1. Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Patient Satisfaction score [ Time Frame: 72 hours ]
  2. Total cost of hospitalization [ Time Frame: 72 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373527


Contacts
Contact: Daniel Sporn, MD sporn_daniel@guthrie.org
Contact: Laura Fitzgerald, MPH 570-887-4656 fitzgerald_laura@guthrie.org

Locations
United States, Pennsylvania
Robert Packer Hospital Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Daniel Sporn, MD       sporn_daniel@guthrie.org   
Sponsors and Collaborators
The Guthrie Clinic
Investigators
Principal Investigator: Daniel Sporn, MD The Guthrie Clinic

Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT02373527     History of Changes
Other Study ID Numbers: 1411-60
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms