Individualized Volume of Oral Contrast Agent in CT Enterography

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.

Study Overview

• Status: Unknown
• Conditions: CTE
• Intervention / Treatment: Drug: 1500ml of 2.5% mannitol; Drug: different volume of 2.5% mannitol

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanqing Li, PhD, MD; Phone Number: 86-531-82169236; Email: liyanqing@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical risk factors for inadequate small bowel distention	Number of clinical risk factors for inadequate small bowel distention	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%"	4 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2019
• Primary Completion (Anticipated): March 20, 2019
• Study Completion (Anticipated): July 20, 2019

Study Registration Dates

• First Submitted: January 12, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: 2019SDU-QILU-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No