NCT04116346

Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events

Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events: Randomized Controlled Trial of Non-inferiority (TONIC)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 736 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Traditionally, patients are asked to fast prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this. Hypothesis/Objective : To show that allowing unrestricted oral intake before a coronary interventional procedure is not inferior to imposing a pre-procedural fasting period, in terms of adverse events, in patients requiring coronary angiography or a planned or semi-urgent percutaneous coronary intervention. Method: The study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms. The investigating physician performing the interventional procedure and evaluating the safety judgment criteria will not be informed of the patient's randomization arm. In order to keep the blind, the medical and paramedical staff of the interventional cardiology room will not inquire about the fasting status of patients included in the study. Patients are randomized either to the pre-procedural fasting arm or to the absence of pre-procedural fasting. * No intervention: Pre-procedural fasting is defined by the absence of ingestion of fluids or solid food for at least 6 hours before the examination. * Experimental: free feeding and drinking until the procedure. Patients are followed for 4 hours after the end of the procedure at the hospital for adverse events (vagal discomfort, nausea, vomiting or hypoglycaemia). Then a follow-up will be done at day 7 after the procedure (by telephone for outpatients or discharged from the hospital and in the cardiology department for patients still hospitalized on D7) to look for the occurrence of acute renal failure or pneumonia

Conditions

• Fasting
• Cardiac Catheterization
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
OTHER	Oral intake allowed	Oral intake (food and fluids) allowed up to the time of the procedure

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-12-07
• Completion: 2022-12-07
• First posted: 2019-10-04
• Last updated: 2019-10-04

Locations

1 site across 1 country: France