Contrast AgentNCT03019341
Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media
An observational study of Contrast Agent and Nausea, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The prevalence of nausea and vomiting after the administration of non-ionic contrast media has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk factors of nausea and vomiting after the exposure to the non-ionic contrast media for computed tomography examinations in adults. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Contrast Agent, Nausea
- How many people
- 1,175 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to 31 Mar 2017
- How long will I take part?
- 1 Day
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo elective CT examination after the administration of non-ionic contrast media in a single tertiary hospital will be enrolled based on following inclusion and exclusion criteria.
Who may be able to join
- Patients undergoing contrast-enhanced CT examination with non-ionic contrast media during regular working hours
- Adult patients (20 years old or older)
- Patients with informed written consent
- Patients under observation by medical staffs during and after CT examination up to 30 minutes.
Who cannot join
- Patients without informed written consent
- Age of patients younger than 20 years old
- Uncooperative patients
- Pediatric, pregnant, and emergent patients
- Patients without sufficient observation by medical staffs during and after CT examination up to 30 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media: Prevalence and Risk Factors
The prevalence of nausea and vomiting after the administration of non-ionic contrast media has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk factors of nausea and vomiting after the exposure to the non-ionic contrast media for computed tomography examinations in adults.
Read the detailed description
There is no robust evidence or guideline for fasting prior to contrast-enhanced CT scan in patients. Substantial heterogeneity exists on fasting prior to contrast-enhanced CT worldwide. Through dedicated questionnaires, the investigators plan to prospectively assess the prevalence and the risk factors for nausea and vomiting after the exposure to the non-ionic contrast media agent in adult patients undergoing computed tomography examinations.
- Conditions
- Contrast Agent, Nausea
- Keywords
- Nausea, Vomiting, Non-ionic contrast media, Side effect
- Medical subject headings
- Nausea, Vomiting
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 |
|---|---|---|
| Patients with enhanced CT scan | Patients undergo CT examination after the administration of non-ionic contrast media for clinical need. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of immediate nausea or vomiting after contrast injection
Patients will be observed for 30 minutes after the administration of the contrast media agent and medical staffs will record and evaluate the patients' status and the severity of gastrointestinal reaction to the contrast media agent such as nausea or vomiting.
Measured: For 30 minutes after administration of non-ionic contrast media
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Contrast AgentStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,175 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Ho Yoon, Seoul National University Hospital
- Investigators
- Soon ho Yoon, Study chair, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019341
- Sponsor's protocol ID
- SeoulNUH_NVICM
- Status last verified
- Apr 2017
- First submitted
- 31 Dec 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lee BY, Ok JJ, Abdelaziz Elsayed AA, Kim Y, Han DH. Preparative fasting for contrast-enhanced CT: reconsideration. Radiology. 2012 May;263(2):444-50. doi: 10.1148/radiol.12111605.
PubMed 22517959Federle MP, Willis LL, Swanson DP. Ionic versus nonionic contrast media: a prospective study of the effect of rapid bolus injection on nausea and anaphylactoid reactions. J Comput Assist Tomogr. 1998 May-Jun;22(3):341-5. doi: 10.1097/00004728-199805000-00001.
PubMed 9606371
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media: Prevalence and Risk Factors
- ClinicalTrials.gov ID
- NCT03019341
- Acronym / sponsor ID
- SeoulNUH_NVICM
- Conditions
- Contrast Agent, Nausea
- Keywords
- Nausea, Vomiting, Non-ionic contrast media, Side effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,175 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 12 Jan 2017 (estimated)
- 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 prevalence of nausea and vomiting after the administration of non-ionic contrast media has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk factors of nausea and vomiting after the exposure to the non-ionic contrast media for computed tomography examinations in adults.
Detailed description
There is no robust evidence or guideline for fasting prior to contrast-enhanced CT scan in patients. Substantial heterogeneity exists on fasting prior to contrast-enhanced CT worldwide. Through dedicated questionnaires, the investigators plan to prospectively assess the prevalence and the risk factors for nausea and vomiting after the exposure to the non-ionic contrast media agent in adult patients undergoing computed tomography examinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with enhanced CT scan | – | –Patients undergo CT examination after the administration of non-ionic contrast media for clinical need. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo elective CT examination after the administration of non-ionic contrast media in a single tertiary hospital will be enrolled based on following inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Patients undergoing contrast-enhanced CT examination with non-ionic contrast media during regular working hours
- Adult patients (20 years old or older)
- Patients with informed written consent
- Patients under observation by medical staffs during and after CT examination up to 30 minutes.
Key exclusion criteria (5 listed)
- Patients without informed written consent
- Age of patients younger than 20 years old
- Uncooperative patients
- Pediatric, pregnant, and emergent patients
- Patients without sufficient observation by medical staffs during and after CT examination up to 30 minutes.
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
Prevalence of immediate nausea or vomiting after contrast injection
Time frame: For 30 minutes after administration of non-ionic contrast media
Patients will be observed for 30 minutes after the administration of the contrast media agent and medical staffs will record and evaluate the patients' status and the severity of gastrointestinal reaction to the contrast media agent such as nausea or vomiting.
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 26 Apr 2017.
- Background: PubMed 22517959Lee BY, Ok JJ, Abdelaziz Elsayed AA, Kim Y, Han DH. Preparative fasting for contrast-enhanced CT: reconsideration. Radiology. 2012 May;263(2):444-50. doi: 10.1148/radiol.12111605.
- Background: PubMed 9606371Federle MP, Willis LL, Swanson DP. Ionic versus nonionic contrast media: a prospective study of the effect of rapid bolus injection on nausea and anaphylactoid reactions. J Comput Assist Tomogr. 1998 May-Jun;22(3):341-5. doi: 10.1097/00004728-199805000-00001.
- Individual participant dataSharing planned: Undecided
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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.
Soon ho Yoon study chair
Seoul National University of Hospital
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 Contrast Agent and Nausea, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 5 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 26 Apr 2017. 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 South Korea. 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?
Prevalence of immediate nausea or vomiting after contrast injection (time frame: For 30 minutes after administration of non-ionic contrast media). 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 NCT03019341, which also lists 2 linked publications.
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 26 Apr 2017.