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

This study is currently recruiting participants.
Verified November 2016 by The Guthrie Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02373527
First Posted: February 27, 2015
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The Guthrie Clinic
  Purpose
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 Intervention
Chest Pain Other: No Fasting prior to catheterization

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Guthrie Clinic:

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

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

Estimated Enrollment: 600
Study Start Date: March 2015
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT02373527     History of Changes
Other Study ID Numbers: 1411-60
First Submitted: February 23, 2015
First Posted: February 27, 2015
Last Update Posted: November 29, 2016
Last Verified: November 2016

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