Individualized Volume of Oral Contrast Agent in CT Enterography

Shandong University

Status: Unknown

Conditions: CTE

Treatments: Drug: different volume of 2.5% mannitol; Drug: 1500ml of 2.5% mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT03808649

2019SDU-QILU-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 2 patient groups

Individualized group

Active Comparator group

Description:

Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.

Treatment:

Drug: 1500ml of 2.5% mannitol

Drug: different volume of 2.5% mannitol

conventional group

Experimental group

Description:

Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination.

Treatment:

Drug: 1500ml of 2.5% mannitol