Individualized Volume of Oral Contrast Agent in CT Enterography

CTE Clinical Trial

Official title:

Individualized Volume of Oral Contrast Agent Based on the Clinical Risk Factor in CT Enterography: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03808649
• Other study ID #: 2019SDU-QILU-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: July 20, 2019

Study information

• Verified date: January 2019
• Source: Shandong University
• Contact: Yanqing Li, PhD, MD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• CTE

Intervention

Drug:
• 1500ml of 2.5% mannitol
1500ml of 2.5% mannitol was used in experimental group
• different volume of 2.5% mannitol
different volume of 2.5% mannitol based on BMI was used in active comparator group

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical risk factors for inadequate small bowel distention	Number of clinical risk factors for inadequate small bowel distention	2 month
Primary	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	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