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

NCT04389697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2021-03-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Helios Health Institute GmbH

    lead OTHER

Principal Investigators

  • Kerstin Bode, MD, MSc · Heart Center Leipzig at the University of Leipzig

  • Alireza Sepehri Shamloo, MD · Heart Center Leipzig at the University of Leipzig

  • Gerhard Hindricks, MD · Heart Center Leipzig at the University of Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2020-11-06
Completion
2020-12-06

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04389697 on ClinicalTrials.gov