ANZCTR - Registration

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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]

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

Vomiting after non-ionic intravenous contrast administration

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

15 and 30 minutes following intravenous injection of contrast media agent.

Secondary outcome [1]

Nil

Timepoint [1]

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?

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]

Spain

State/province [1]

Almeria

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Torrecardenas University Hospital

Address [1]

Hermandad donantes de sangre street, N/N.
04009-Almeria

Country [1]

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]

Hospital

Name [1]

Torrecardenas University Hospital

Address [1]

Hermandad donantes de sangre, N/N
04009-Almeria

Country [1]

Spain

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comite de etica de la investigación provincial de Almeria

Ethics committee address [1]

Torrecardenas University Hospital, 7th floor.
Hermandad donantes de sangre street, N/N
04009-Almeria.

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

Approval date [1]

29/09/2021

Ethics approval number [1]

Summary

Brief summary

This randomized study aims to evaluate the incidence of nausea, vomiting, and other acute adverse reactions associated with the intravenous administration of non-ionic contrast media in outpatients undergoing non-emergency contrast-enhanced CT and to identify potential risk factors for the occurrence of these acute adverse reactions. Preparatory fasting prior to contrast-enhanced CT studies may be unnecessary.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Teresa Góngora Lencina

Address

Torrecardenas University Hospital, ground floor.
Hermandad donantes de sangre street, N/N
04009-Almería.

Country

Spain

Phone

+34652311640

Fax

teresu_82@hotmail.com

Contact person for public queries

Name

Maricela Moreira Cabrera

Address

Torrecardenas University Hospital, ground floor.
Hermandad donantes de sangre street, N/N
04009-Almería.

Country

Spain

Phone

+34653269552

Fax

moreiramaricela@gmail.com

Contact person for scientific queries

Name

Maricela Moreira Cabrera

Address

Torrecardenas University Hospital, ground floor.
Hermandad donantes de sangre street, N/N
04009-Almería.

Country

Spain

Phone

+34653269552

Fax

moreiramaricela@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17631	Informed consent form					384985-(Uploaded-14-11-2022-23-28-33)-Study-related document.pdf
17632	Ethical 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.

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