Individualized Volume of Oral Contrast Agent in CT Enterography

• ClinicalTrials.gov Identifier: NCT03808649
• Recruitment Status: Unknown
• First Posted: January 17, 2019
• Last Update Posted: January 23, 2019
• Sponsor: Shandong University
• Information provided by (Responsible Party): Yanqing Li, Shandong University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
CTE	Drug: 1500ml of 2.5% mannitol; Drug: different volume of 2.5% mannitol	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Individualized Volume of Oral Contrast Agent Based on the Clinical Risk Factor in CT Enterography: a Randomized Controlled Trial
• Estimated Study Start Date: January 20, 2019
• Estimated Primary Completion Date: March 20, 2019
• Estimated Study Completion Date: July 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Individualized group; Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.	Drug: 1500ml of 2.5% mannitol; 1500ml of 2.5% mannitol was used in experimental group; Drug: different volume of 2.5% mannitol; different volume of 2.5% mannitol based on BMI was used in active comparator group
Experimental: conventional group; Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination.	Drug: 1500ml of 2.5% mannitol; 1500ml of 2.5% mannitol was used in experimental group

Outcome Measures

Primary Outcome Measures :

1. Clinical risk factors for inadequate small bowel distention [ Time Frame: 2 month ]
   Number of clinical risk factors for inadequate small bowel distention
2. 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%"

Secondary Outcome Measures :

1. Side effects [ Time Frame: 4 month ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• patients undergoing CT enterography

Exclusion Criteria:

• 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
• patients with documented allergy to intravascular contrast agent
• patients with pregnancy or lactation
• patients hemodynamically unstable
• patients unable to give informed consent.

Contacts and Locations

Contacts

Contact: Yanqing Li, PhD, MD; 86-531-82169236; liyanqing@sdu.edu.cn

Locations

China, Shandong

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China, 250012

Contact: Yanqing Li, MD, PhD 86-531-82169236 liyanqing@sdu.edu.cn

Sponsors and Collaborators

Shandong University

Investigators

• Principal Investigator: Yanqing Li, PhD, MD; Qilu Hospital, Shandong University

More Information

• Responsible Party: Yanqing Li, vice president of Qilu Hospital, Shandong University
• ClinicalTrials.gov Identifier: NCT03808649
• Other Study ID Numbers: 2019SDU-QILU-01
• First Posted: January 17, 2019
• Last Update Posted: January 23, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Mannitol; Diuretics, Osmotic; Diuretics; Natriuretic Agents; Physiological Effects of Drugs