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

March 15, 2021 updated by: Leipzig Heart Institute GmbH
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patients well-being
Time Frame: During the first 24 hours after the procedure
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usages of inotropic and vasopressor agents
Time Frame: During the intervention
Amount of used inotropic and vasopressor agents during the intervention
During the intervention
Usage of sedatives
Time Frame: During the intervention
Amount of used sedative agents during the intervention
During the intervention
Usage of analgesics
Time Frame: During the intervention
Amount of used analgesics agents during the intervention
During the intervention
Usage anti-vomiting agents
Time Frame: During the intervention
Amount of used anti-vomiting agents during the intervention
During the intervention
Serum creatinine level
Time Frame: 1 hour pre-procedural, during the first 24 hours after the procedure
Serum creatinine (mg/dL)
1 hour pre-procedural, during the first 24 hours after the procedure
Serum urea level
Time Frame: 1 hour pre-procedural, during the first 24 hours after the procedure
Serum urea (mg/dL)
1 hour pre-procedural, during the first 24 hours after the procedure
eGFR
Time Frame: 1 hour pre-procedural, during the first 24 hours after the procedure
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
Time Frame: pre-intervention, and then every 15 minutes during the procedure
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
Time Frame: pre-intervention, and then every 15 minutes during the procedure
Oxygen saturation (%) will be assessed by using a monitoring device
pre-intervention, and then every 15 minutes during the procedure
Blood pressure
Time Frame: pre-intervention, and then every 15 minutes during the procedure
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
Time Frame: 1 hour pre-procedural
Will be assessed by venous blood gas analysis (number).
1 hour pre-procedural
blood PaCo2
Time Frame: 1 hour pre-procedural
Will be assessed by venous blood gas analysis (mmHg).
1 hour pre-procedural
blood HCO3
Time Frame: 1 hour pre-procedural
Will be assessed by venous blood gas analysis (mEq/L).
1 hour pre-procedural
blood sugar
Time Frame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure
Will be assessed by venous blood gas analysis (mg/dL).
1 hour pre-procedural, pre-intervention, 8 hours after procedure
Sodium
Time Frame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure
Will be assessed by blood test.
1 hour pre-procedural, pre-intervention, 8 hours after procedure
Potassium
Time Frame: 1 hour pre-procedural, pre-intervention, 8 hours after procedure
Will be assessed by blood test (mm/L).
1 hour pre-procedural, pre-intervention, 8 hours after procedure
Patients general satisfaction
Time Frame: During the first 24 hours after the procedure
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
Time Frame: During the first 24 hours after the procedure
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
Time Frame: During the first 24 hours after the procedure
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
Time Frame: Up to 30 days
Based on the number of ICU stay nights
Up to 30 days
Length of hospital stay
Time Frame: Up to 30 days
Based on the number of ICU stay nights plus ward stay
Up to 30 days
Operation site infection rate
Time Frame: During 30 days after the procedure
Operation site (Chest) infection rate via Telephone /follow-up visits
During 30 days after the procedure
Incidence of death
Time Frame: During 30 days after the procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leipzig Heart Institute GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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