CTENCT03808649
Individualized Volume of Oral Contrast Agent in CT Enterography
A study testing 1500ml of 2.5% mannitol and different volume of 2.5% mannitol in people with CTE, run by Shandong University at 1 site in China.
Trial summary
Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography, but some patients were sufferring inadequate small bowel distension. So, it is important to prescribe personalized regimen according to patient's personal characteristics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CTE
- What is being tested?
- 1500ml of 2.5% mannitol and different volume of 2.5% mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2019to 20 Jul 2019
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing CT enterography
Who cannot join
- patients with a history of GI surgery
- patients with known or suspected bowel obstruction or perforation
- patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- patients with acute upper GI bleeding
- patients with severe inflammatory bowel disease or megacolon
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- patients with documented allergy to intravascular contrast agent
- patients with pregnancy or lactation
- patients hemodynamically unstable
- patients unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD, PhD, 86-531-82169236, liyanqing@sdu.edu.cn
About this study
Official title: Individualized Volume of Oral Contrast Agent Based on the Clinical Risk Factor in CT Enterography: a Randomized Controlled Trial
Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography, but some patients were sufferring inadequate small bowel distension. So, it is important to prescribe personalized regimen according to patient's personal characteristics.
Read the detailed description
CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory for the assessment of the bowel wall. So, it is important to find clinical risk factors for inadequate small bowel distension and prescribe personalized regimen according to patient's personal characteristics to reduce patient acceptance.
- Conditions
- CTE
- Being tested
- 1500ml of 2.5% mannitol, different volume of 2.5% mannitol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1500ml of 2.5% mannitolDrug
1500ml of 2.5% mannitol was used in experimental group
different volume of 2.5% mannitolDrug
different volume of 2.5% mannitol based on BMI was used in active comparator group
| Study group | Role | What they receive |
|---|---|---|
| Individualized group | Active comparator | Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination. Receives: Drug: 1500ml of 2.5% mannitol; Drug: different volume of 2.5% mannitol |
| conventional group | Experimental | Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination. Receives: Drug: 1500ml of 2.5% mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical risk factors for inadequate small bowel distention
Number of clinical risk factors for inadequate small bowel distention
Measured: 2 month
Adequate small bowel distention
The assessment system includes four parts
- Whether the contrast reached the caecum is evaluate and recorded as "yes" or "no"
- The overall presence of inhomogeneous contrast is evaluated and recorded as "yes" or "no"
- The maximum dimension of a single loop in each quadrant was recorded.
- The scale of loops of small bowel distended are evaluated and recorded as "0%-25%","26%-50%","51%-75%","75%-100%"
Measured: 4 month
Secondary outcomes (1)
Side effects
Side effects in 2 groups The degree of nausea, emesis, diarrhea, abdominal distension and cramp following ingestion are scored on a scale ranging from 0 to 4, in which a higher score represents a higher level of these targets.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start20 Jan 2019 (estimated)
- Primary completion20 Mar 2019 (estimated)
- Study completion20 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTEStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808649
- Sponsor's protocol ID
- 2019SDU-QILU-01
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Volume of Oral Contrast Agent Based on the Clinical Risk Factor in CT Enterography: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03808649
- Acronym / sponsor ID
- 2019SDU-QILU-01
- Conditions
- CTE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (estimated)
- Primary completion
- 20 Mar 2019 (estimated)
- Study completion
- 20 Jul 2019 (estimated)
- First posted
- 17 Jan 2019 (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.
Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography, but some patients were sufferring inadequate small bowel distension. So, it is important to prescribe personalized regimen according to patient's personal characteristics.
Detailed description
CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory for the assessment of the bowel wall. So, it is important to find clinical risk factors for inadequate small bowel distension and prescribe personalized regimen according to patient's personal characteristics to reduce patient acceptance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized group | Active comparator | Drug: 1500ml of 2.5% mannitol, Drug: different volume of 2.5% mannitolParticipants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination. |
| conventional group | Experimental | Drug: 1500ml of 2.5% mannitolParticipants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing CT enterography
Key exclusion criteria (10 listed)
- patients with a history of GI surgery
- patients with known or suspected bowel obstruction or perforation
- patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- patients with acute upper GI bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1500ml of 2.5% mannitol1500ml of 2.5% mannitol was used in experimental group | Drug | Individualized group, conventional group |
| different volume of 2.5% mannitoldifferent volume of 2.5% mannitol based on BMI was used in active comparator group | Drug | Individualized group |
Primary outcome
Clinical risk factors for inadequate small bowel distention
Time frame: 2 month
Number of clinical risk factors for inadequate small bowel distention
Adequate small bowel distention
Time frame: 4 month
The assessment system includes four parts 1. Whether the contrast reached the caecum is evaluate and recorded as "yes" or "no" 2. The overall presence of inhomogeneous contrast is evaluated and recorded as "yes" or "no" 3. The maximum dimension of a single loop in each quadrant was recorded. 4. The scale of loops of small bowel distended are evaluated and recorded as "0%-25%","26%-50%","51%-75%","75%-100%"
1 secondary outcome
Side effects
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
Yanqing Li, PhD, MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1500ml of 2.5% mannitol and different volume of 2.5% mannitol in people with CTE, run by Shandong University at 1 site in China.
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 10 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: status not confirmed, as of the sponsor's last update on 23 Jan 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, PhD, MD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical risk factors for inadequate small bowel distention (time frame: 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019.