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Cardiac Implantable Electronic DevicesNCT04389697

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

A study testing Clear fluids and food up to up to 1 hour before the procedure in people with Cardiac Implantable Electronic Devices, run by Helios Health Institute GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Implantable Electronic Devices
What is being tested?
Clear fluids and food up to up to 1 hour before the procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
1 siteGermany
Study dates
29 Jan 2020to 6 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Electrophysiology, Leipzig Heart Center

    Leipzig, Saxony, 04289

Other trials in Germany

About this 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

Being tested
Clear fluids and food up to up to 1 hour before the procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clear fluids and food up to up to 1 hour before the procedureDietary supplement

    Clear fluids and food up to up to 1 hour before the start of the procedure

Study groups in NCT04389697
Study groupRoleWhat they receive
Intervention armExperimentalClear fluids and food up to up to 1 hour before the procedure
Receives: Dietary Supplement: Clear fluids and food up to up to 1 hour before the procedure
Control armNo interventionFasting for solids for up to 6 hours and fluids up to 2 hours before the procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: During the first 24 hours after the procedure

Secondary outcomes (23)

  1. Usages of inotropic and vasopressor agents

    Amount of used inotropic and vasopressor agents during the intervention

    Measured: During the intervention

  2. Usage of sedatives

    Amount of used sedative agents during the intervention

    Measured: During the intervention

  3. Usage of analgesics

    Amount of used analgesics agents during the intervention

    Measured: During the intervention

  4. Usage anti-vomiting agents

    Amount of used anti-vomiting agents during the intervention

    Measured: During the intervention

  5. Serum creatinine level

    Serum creatinine (mg/dL)

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

  6. Serum urea level

    Serum urea (mg/dL)

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

  7. 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.

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

  8. Heart rate

    Heart rate (frequency per minute) will be assessed by using a monitoring device

    Measured: pre-intervention, and then every 15 minutes during the procedure

  9. Oxygen saturation

    Oxygen saturation (%) will be assessed by using a monitoring device

    Measured: pre-intervention, and then every 15 minutes during the procedure

  10. Blood pressure

    Systolic and diastolic blood pressure (mmHg) will be assessed by using a monitoring device

    Measured: pre-intervention, and then every 15 minutes during the procedure

  11. blood pH

    Will be assessed by venous blood gas analysis (number).

    Measured: 1 hour pre-procedural

  12. blood PaCo2

    Will be assessed by venous blood gas analysis (mmHg).

    Measured: 1 hour pre-procedural

  13. blood HCO3

    Will be assessed by venous blood gas analysis (mEq/L).

    Measured: 1 hour pre-procedural

  14. blood sugar

    Will be assessed by venous blood gas analysis (mg/dL).

    Measured: 1 hour pre-procedural, pre-intervention, 8 hours after procedure

  15. Sodium

    Will be assessed by blood test.

    Measured: 1 hour pre-procedural, pre-intervention, 8 hours after procedure

  16. Potassium

    Will be assessed by blood test (mm/L).

    Measured: 1 hour pre-procedural, pre-intervention, 8 hours after procedure

  17. 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)

    Measured: During the first 24 hours after the procedure

  18. Sleep quality

    Sleep quality based on Numeric Rating Scale (rang: 0-10, higher scores mean a better outcome)

    Measured: During the first 24 hours after the procedure

  19. Surgical site pain

    Surgical site pain based on Numeric Rating Scale (rang: 0-10, higher scores mean a worse outcome)

    Measured: During the first 24 hours after the procedure

  20. Length of ICU stay

    Based on the number of ICU stay nights

    Measured: Up to 30 days

  21. Length of hospital stay

    Based on the number of ICU stay nights plus ward stay

    Measured: Up to 30 days

  22. Operation site infection rate

    Operation site (Chest) infection rate via Telephone /follow-up visits

    Measured: During 30 days after the procedure

  23. Incidence of death

    The investigators will then divide the causes into 1) operation related and 2) non-operation related causes

    Measured: During 30 days after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start29 Jan 2020
  3. Primary completion6 Nov 2020
  4. Study completion6 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04389697
Sponsor's protocol ID
2019-0310
Status last verified
Mar 2021
First submitted
20 Dec 2019
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35726877

Questions about this trial

What is this clinical trial studying?

A study testing Clear fluids and food up to up to 1 hour before the procedure in people with Cardiac Implantable Electronic Devices, run by Helios Health Institute GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients well-being (time frame: During the first 24 hours after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04389697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.

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