Clinical trial NCT04389697: Fasting Versus Non-Fasting for Cardiac Implantable Electronic Devices (FastCIED Study)
Official title: Fasting Versus Non-Fasting for Cardiac Implantable Electronic Devices (FastCIED Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Implantable Electronic Devices
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There was no evidence to suggest that a shortened fluid fast results in an increased risk of aspiration, regurgitation or related morbidity compared with the standard 'nil by mouth from midnight' fasting policy. However, there is no available data regarding the safety and efficacy of fasting approach in patients undergoing cardiac implantable electronic device (CIED) procedures. The aim of this study is to demonstrate that a non-fasting protocol is non-inferior in regard to safety to a fasting protocol (current practice) in patients undergoing cardiac device implantation procedures


Eligibility criteria: Inclusion Criteria:

* All patients \>18 years undergoing elective implantation or generator exchange of cardiac implantable electronic devices

Exclusion Criteria:

* Patients presenting with an acute unstable condition (bradycardia \< 30/min or temporary pacing wire)
* Patients scheduled for deep sedation
* Patients with increased intra-abdominal pressure (severe intra-abdominal tumors, severe ascites, very severe obesity: BMI\>40 kg/m2).

Primary outcomes:
measure: Patients well-being
timeFrame: During the first 24 hours after the procedure
Secondary outcomes:
measure: Usages of inotropic and vasopressor agents
timeFrame: During the intervention
measure: Usage of sedatives
timeFrame: During the intervention
measure: Usage of analgesics
timeFrame: During the intervention
measure: Usage anti-vomiting agents
timeFrame: During the intervention
measure: Serum creatinine level
timeFrame: 1 hour pre-procedural, during the first 24 hours after the procedure
measure: Serum urea level
timeFrame: 1 hour pre-procedural, during the first 24 hours after the procedure
measure: eGFR
timeFrame: 1 hour pre-procedural, during the first 24 hours after the procedure
measure: Heart rate
timeFrame: pre-intervention, and then every 15 minutes during the procedure
measure: Oxygen saturation
timeFrame: pre-intervention, and then every 15 minutes during the procedure
measure: Blood pressure
timeFrame: pre-intervention, and then every 15 minutes during the procedure
measure: blood pH
timeFrame: 1 hour pre-procedural
measure: blood PaCo2
timeFrame: 1 hour pre-procedural
measure: blood HCO3
timeFrame: 1 hour pre-procedural
measure: blood sugar
timeFrame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure
measure: Sodium
timeFrame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure
measure: Potassium
timeFrame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure
measure: Patients general satisfaction
timeFrame: During the first 24 hours after the procedure
measure: Sleep quality
timeFrame: During the first 24 hours after the procedure
measure: Surgical site pain
timeFrame: During the first 24 hours after the procedure
measure: Length of ICU stay
timeFrame: Up to 30 days
measure: Length of hospital stay
timeFrame: Up to 30 days
measure: Operation site infection rate
timeFrame: During 30 days after the procedure
measure: Incidence of death
timeFrame: During 30 days after the procedure
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Electrophysiology, Leipzig Heart Center
state: Saxony
Study officials:
affiliation: Heart Center Leipzig at the University of Leipzig
name: Kerstin Bode, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Leipzig at the University of Leipzig
name: Alireza Sepehri Shamloo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Leipzig at the University of Leipzig
name: Gerhard Hindricks, MD
role: STUDY_CHAIR
References:
citation: Bode K, Gerhards M, Doering M, Lucas J, Tijssen J, Dagres N, Hilbert S, Richter S, Nedios S, Lurz J, Moscoso-Luduena C, Arya A, Shamloo AS, Hindricks G. A randomized trial of non-fasting vs. fasting for cardiac implantable electronic device procedures (Fast-CIED Study). Europace. 2022 Oct 13;24(10):1617-1626. doi: 10.1093/europace/euac081.