NCT03533348

Brief Summary

The study aims to determine whether there is a need for preparative fasting prior to contrast-enhanced computed tomography (CT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,148

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

April 30, 2018

Last Update Submit

October 21, 2019

Conditions

X-ray Contrast Media Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Aspiration pneumonitis

    Rates of aspiration pneumonitis after contrast-enhanced CT scans

    Day 1

Secondary Outcomes (1)

  • Gastrointestinal symptoms

    Hour 1

Study Arms (2)

Fasting arm

Patients will need at least 4 hours of fasting prior to contrast-enhanced CT scans.

No fasting

Patients are allowed to eat and drink freely prior to contrast-enhanced CT scans.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants are inpatients who are undergoing contrast enhanced computed tomography that will be divided into two cohorts. The first will need at least 4 hours of fasting prior to contrast enhanced computed tomography scans and the second will be allowed to eat and drink freely prior to contrast enhanced computed tomography scans

You may qualify if:

  • \- Patients undergoing contrast-enhanced CT scans

You may not qualify if:

  • Pateints undergoing CT scans while sedated.
  • Patients under the age of 18 years
  • Patients who suffer from a mental disorder that prevents them:
  • from understanding what s/he consents to and/ or
  • from choosing decisively and/ or
  • from communicating his/her consent
  • Patients who were instructed not to eat due to requirements of a specific study (for example.. computed tomography enterography-CTE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emek Medical Center

Afula, 18341, Israel

Location

Related Publications (1)

  • Neeman Z, Abu Ata M, Touma E, Saliba W, Barnett-Griness O, Gralnek IM, Rock W, Bisharat N. Is fasting still necessary prior to contrast-enhanced computed tomography? A randomized clinical study. Eur Radiol. 2021 Mar;31(3):1451-1459. doi: 10.1007/s00330-020-07255-0. Epub 2020 Sep 8.

    PMID: 32901302DERIVED

Study Officials

  • Naiel Bisharat, MD

    Emek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Department of Medicine D

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 23, 2018

Study Start

July 31, 2018

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

IL(1)