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

NCT04389697 | Completed

• 1 other identifier: 2019-0310
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Implantable Electronic Devices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Usages of inotropic and vasopressor agents

  During the intervention

• Usage of sedatives

  During the intervention

• Usage of analgesics

  During the intervention

• Usage anti-vomiting agents

  During the intervention

• Serum creatinine level

  1 hour pre-procedural, during the first 24 hours after the procedure

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Fasting for solids for up to 6 hours and fluids up to 2 hours before the procedure

Interventions

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 start of the procedure

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Helios Health Institute GmbH: lead

Study Sites (1)

Department of Electrophysiology, Leipzig Heart Center

Leipzig, Saxony, 04289, Germany

Location

Related Publications (1)

• 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.

  PMID: 35726877 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Gerhard Hindricks, MD

  Heart Center Leipzig at the University of Leipzig

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: May 15, 2020
• Study Start: January 29, 2020
• Primary Completion: November 6, 2020
• Study Completion: December 6, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

DE (1)