Fasting Versus Non-Fasting for Cardiac Implantable Electronic Devices (FastCIED Study)

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

Study Overview

• Status: Completed
• Conditions: Cardiac Implantable Electronic Devices
• Intervention / Treatment: Dietary supplement: Clear fluids and food up to up to 1 hour before the procedure

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Department of Electrophysiology, Leipzig Heart Center

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:

• 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Clear fluids and food up to up to 1 hour before the procedure	Dietary supplement: Clear fluids and food up to up to 1 hour before the procedure; Clear fluids and food up to up to 1 hour before the start of the procedure
No Intervention: Control arm; Fasting for solids for up to 6 hours and fluids up to 2 hours before the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients well-being	Post-interventional patients well-being including (to be assessed by questionnaire with the help of a Numeric Rating Scale (rang: 0-10, higher scores mean a worse outcome): abdominal pain, thirst, mouth dryness, headache, anxiety, hunger, nausea, vomiting, tiredness and weakness, dizziness Incidence of Intra -procedural adverse events like emergency intubation and perioperative pulmonary aspiration vomiting)	During the first 24 hours after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usages of inotropic and vasopressor agents	Amount of used inotropic and vasopressor agents during the intervention	During the intervention
Usage of sedatives	Amount of used sedative agents during the intervention	During the intervention
Usage of analgesics	Amount of used analgesics agents during the intervention	During the intervention
Usage anti-vomiting agents	Amount of used anti-vomiting agents during the intervention	During the intervention
Serum creatinine level	Serum creatinine (mg/dL)	1 hour pre-procedural, during the first 24 hours after the procedure
Serum urea level	Serum urea (mg/dL)	1 hour pre-procedural, during the first 24 hours after the procedure
eGFR	GFR is Glomerular Filtration Rate and it is a key indicator of renal function. eGFR is estimated GFR and is a mathematically derived entity based on a patient's serum creatinine level, age, sex and race.	1 hour pre-procedural, during the first 24 hours after the procedure
Heart rate	Heart rate (frequency per minute) will be assessed by using a monitoring device	pre-intervention, and then every 15 minutes during the procedure
Oxygen saturation	Oxygen saturation (%) will be assessed by using a monitoring device	pre-intervention, and then every 15 minutes during the procedure
Blood pressure	Systolic and diastolic blood pressure (mmHg) will be assessed by using a monitoring device	pre-intervention, and then every 15 minutes during the procedure
blood pH	Will be assessed by venous blood gas analysis (number).	1 hour pre-procedural
blood PaCo2	Will be assessed by venous blood gas analysis (mmHg).	1 hour pre-procedural
blood HCO3	Will be assessed by venous blood gas analysis (mEq/L).	1 hour pre-procedural
blood sugar	Will be assessed by venous blood gas analysis (mg/dL).	1 hour pre-procedural, pre-intervention, 8 hours after procedure
Sodium	Will be assessed by blood test.	1 hour pre-procedural, pre-intervention, 8 hours after procedure
Potassium	Will be assessed by blood test (mm/L).	1 hour pre-procedural, pre-intervention, 8 hours after procedure
Patients general satisfaction	Patients general satisfaction with procedure as assessed by the patient satisfaction survey form using Numeric Rating Scale (rang: 0-10, higher scores mean a better outcome)	During the first 24 hours after the procedure
Sleep quality	Sleep quality based on Numeric Rating Scale (rang: 0-10, higher scores mean a better outcome)	During the first 24 hours after the procedure
Surgical site pain	Surgical site pain based on Numeric Rating Scale (rang: 0-10, higher scores mean a worse outcome)	During the first 24 hours after the procedure
Length of ICU stay	Based on the number of ICU stay nights	Up to 30 days
Length of hospital stay	Based on the number of ICU stay nights plus ward stay	Up to 30 days
Operation site infection rate	Operation site (Chest) infection rate via Telephone /follow-up visits	During 30 days after the procedure
Incidence of death	The investigators will then divide the causes into 1) operation related and 2) non-operation related causes	During 30 days after the procedure

Collaborators and Investigators

• Sponsor: Leipzig Heart Institute GmbH
• Investigators: Principal Investigator: Kerstin Bode, MD, MSc, Heart Center Leipzig at the University of Leipzig; Principal Investigator: Alireza Sepehri Shamloo, MD, Heart Center Leipzig at the University of Leipzig; Study Chair: Gerhard Hindricks, MD, Heart Center Leipzig at the University of Leipzig

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): December 6, 2020

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019-0310

Drug and device information, study documents

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