X-ray Contrast Media Adverse ReactionNCT03533348
Preparative Fasting Before Contrast-enhanced Computed Tomography
An observational study of X-ray Contrast Media Adverse Reaction, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The study aims to determine whether there is a need for preparative fasting prior to contrast-enhanced computed tomography (CT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- X-ray Contrast Media Adverse Reaction
- How many people
- 2,148 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Jul 2018to 10 Oct 2019
- Phase
- Observational
- 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
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
Who may be able to join
- Patients undergoing contrast-enhanced CT scans
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preparative Fasting for Contrast-enhanced Computed tomography-a Prospective Randomized Study
The study aims to determine whether there is a need for preparative fasting prior to contrast-enhanced computed tomography (CT).
Read the detailed description
The use of fasting orders for imaging and other procedures is common, this seemingly benign practice can lead to real harms to patients and poor satisfaction with their care. The nothing per os (NPO) order is sometimes used in CT scans because gastrointestinal tract contents can interrupt visualization of the intestinal lumen, but more commonly NPO orders are are thought to protect all supine patients from aspiration during delivery of intravenous contrast. There is limited evidence to support such practice of NPO orders prior to contrast-enhanced CT scans. The authors' main objective is to determine if there is a need for preparative fasting prior to contrast-enhanced CT scans.
- Conditions
- X-ray Contrast Media Adverse Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspiration pneumonitis
Rates of aspiration pneumonitis after contrast-enhanced CT scans
Measured: Day 1
Secondary outcomes (1)
Gastrointestinal symptoms
Rates of nausea and vomiting after contrast-enhanced CT scans
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start31 Jul 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for X-ray Contrast Media Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,148 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naiel Bisharat, HaEmek Medical Center, Israel
- Investigators
- Naiel Bisharat, MD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533348
- Sponsor's protocol ID
- 0167-17-EMC
- Status last verified
- Oct 2019
- First submitted
- 30 Apr 2018
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32901302
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparative Fasting for Contrast-enhanced Computed tomography-a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03533348
- Acronym / sponsor ID
- 0167-17-EMC
- Conditions
- X-ray Contrast Media Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,148 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine whether there is a need for preparative fasting prior to contrast-enhanced computed tomography (CT).
Detailed description
The use of fasting orders for imaging and other procedures is common, this seemingly benign practice can lead to real harms to patients and poor satisfaction with their care. The nothing per os (NPO) order is sometimes used in CT scans because gastrointestinal tract contents can interrupt visualization of the intestinal lumen, but more commonly NPO orders are are thought to protect all supine patients from aspiration during delivery of intravenous contrast. There is limited evidence to support such practice of NPO orders prior to contrast-enhanced CT scans. The authors' main objective is to determine if there is a need for preparative fasting prior to contrast-enhanced CT scans.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients undergoing contrast-enhanced CT scans
Key exclusion criteria (7 listed)
- Pateints undergoing CT scans while sedated.
- Patients under the age of 18 years
- Patients who suffer from a mental disorder that prevents them:
- Patients who were instructed not to eat due to requirements of a specific study (for example.. computed tomography enterography-CTE)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aspiration pneumonitis
Time frame: Day 1
Rates of aspiration pneumonitis after contrast-enhanced CT scans
1 secondary outcome
Gastrointestinal symptoms
Time frame: Hour 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Derived from this study: PubMed 32901302Neeman 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naiel Bisharat, MD principal investigator
Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of X-ray Contrast Media Adverse Reaction, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 7 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 22 Oct 2019. 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 Israel. 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?
Aspiration pneumonitis (time frame: Day 1). 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 NCT03533348, 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 22 Oct 2019.