Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000071628
Ethics application status
Approved
Date submitted
15/11/2022
Date registered
23/01/2023
Date last updated
6/02/2023
Date data sharing statement initially provided
23/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The end of fasting before contrast-enhanced computed tomography? A prospective study in adults
Scientific title
The effect of fasting prior to non-emergency contrast-enhanced computed tomography on the incidence of non-ionic intravenous contrast-induced adverse reactions in adults: A randomised clinical trial
Secondary ID [1] 308411 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea after non-ionic intravenous contrast administration 328215 0
Vomiting after non-ionic intravenous contrast administration 328216 0
Condition category
Condition code
Oral and Gastrointestinal 325264 325264 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves non-hospitalized subjects, aged 18 years or older, who are refer to the radiology department for a non-emergency contrast-enhanced computed tomography (CT) during regular working hours on a weekday at our hospital (Monday to Friday, from 08:30 to 15:00).

Participants will be approached by their physicians and upon their acceptance to participate in the study, written consent will be obtain.

Participants will be randomly assigned to either the intervention arm (unrestricted consumption of solids up to the time of the CT) or the control group (solid food fasting). There will be no fluids and/or medication ingestion restriction for any arm of the study.

The subjects will be notified about their assignment arm (fasting or non-fasting) by the department nurses the week before the CT scan.

A record sheet self-designed by our group will be used to register the date of examination, basic information of the patients (gender, age, body weight, height and body mass index), the fasting status (fasted or non-fasted participant), the intravenous contrast media induced adverse reactions history and other allergy history, underlying diseases, the examination parts, the name, dose and injection rate of ICMs and the occurrence condition, occurrence time, accompanying symptoms and outcome of ADR.

Full-time nurses will assess and screen the patient’s item by item according to the sheet contents, completed and archived them.

Five 64 multidetector CT scans will be used. Different imaging protocols will be followed depending on the clinical indication or anatomic region examined (head and neck, chest, abdominopelvic and vascular).

All contrast-enhanced CT examinations will be performed with one single type of intravenous nonionic contact media injected by a high-pressure injector using a 18, 20 and 22 G needle. The intravenous injection rate will be 1 to 5 ml/s.
The contrast media to be used will be Ioversol at the concentration of 300, 320 and 350 mg iodine per milligram according to the purpose of the CT scan, based on our institutional. protocol.
The time of the intravenous contrast media administration before the CT examination will depend on the purpose of the examination. The injection doses and rates of contrast media will be selected according to the patient weight and the purpose of CT examinations, based on our institutional protocol.
The duration of the CT scan will vary according to the purpose of the examination and the discretion of the radiologist.
Intervention code [1] 324866 0
Prevention
Comparator / control treatment
At least 6 hours of fasting from solids before before the injection of intravenous contrast media. There will be no fluids and/or medication ingestion restriction.

A record sheet self-designed by our group will be used to register the date of examination, basic information of the patients (gender, age, body weight, height and body mass index), the fasting status (fasted or non-fasted participant), the intravenous contrast media induced adverse reactions history and other allergy history, underlying diseases, the examination parts, the name, dose and injection rate of ICMs and the occurrence condition, occurrence time, accompanying symptoms and outcome of ADR.

Full-time nurses will assess and screen the patient’s item by item according to the sheet contents, completed and archived them.
Control group
Active

Outcomes
Primary outcome [1] 333117 0
Incidence, timing, and severity of adverse reactions (e.g. nausea, vomiting) after administration of intravenous non-ionic contrast media assessed using a record sheet self-designed by our group.
Timepoint [1] 333117 0
15 and 30 minutes following intravenous injection of contrast media agent.
Secondary outcome [1] 415872 0
Nil
Timepoint [1] 415872 0
Nil

Eligibility
Key inclusion criteria
Patients must be scheduled for a non-emergency contrast-enhanced CT scan during weekdays and be equal to or older than 18 years in order to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Incomplete form data filling, presence of intravenous contrast extravasation, intake of antiemetic and prokinetic medication 8 to 12 hours before the examination, patients with overt hyperthyroidism, history of allergic reaction or hypersensitivity to iodinated contrast media and patients unable to provide written informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/10/2021
Date of last participant enrolment
Anticipated
31/01/2023
Actual
1/12/2022
Date of last data collection
Anticipated
3/02/2023
Actual
31/01/2023
Sample size
Target
1500
Accrual to date
Final
1148
Recruitment outside Australia
Country [1] 25136 0
Spain
State/province [1] 25136 0
Almeria

Funding & Sponsors
Funding source category [1] 312663 0
Hospital
Name [1] 312663 0
Torrecardenas University Hospital
Country [1] 312663 0
Spain
Primary sponsor type
Charities/Societies/Foundations
Name
Fundación para la Investigación Biosanitaria en Andalucía Oriental (FIBAO)
Address
Av. de Madrid, 15
18012 - Granada
Country
Spain
Secondary sponsor category [1] 314274 0
Hospital
Name [1] 314274 0
Torrecardenas University Hospital
Address [1] 314274 0
Hermandad donantes de sangre, N/N
04009-Almeria
Country [1] 314274 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311967 0
Comite de etica de la investigación provincial de Almeria
Ethics committee address [1] 311967 0
Ethics committee country [1] 311967 0
Spain
Date submitted for ethics approval [1] 311967 0
Approval date [1] 311967 0
29/09/2021
Ethics approval number [1] 311967 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122998 0
Dr Teresa Góngora Lencina
Address 122998 0
Torrecardenas University Hospital, ground floor.
Hermandad donantes de sangre street, N/N
04009-Almería.
Country 122998 0
Spain
Phone 122998 0
+34652311640
Fax 122998 0
Email 122998 0
[email protected]
Contact person for public queries
Name 122999 0
Maricela Moreira Cabrera
Address 122999 0
Torrecardenas University Hospital, ground floor.
Hermandad donantes de sangre street, N/N
04009-Almería.
Country 122999 0
Spain
Phone 122999 0
+34653269552
Fax 122999 0
Email 122999 0
[email protected]
Contact person for scientific queries
Name 123000 0
Maricela Moreira Cabrera
Address 123000 0
Torrecardenas University Hospital, ground floor.
Hermandad donantes de sangre street, N/N
04009-Almería.
Country 123000 0
Spain
Phone 123000 0
+34653269552
Fax 123000 0
Email 123000 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17631Informed consent form    384985-(Uploaded-14-11-2022-23-28-33)-Study-related document.pdf
17632Ethical approval    384985-(Uploaded-14-11-2022-23-30-04)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.