Ondansetron for symptoms of gastroparesis in patients with chronic kidney disease undergoing hemodialysis

Phase 3

Recruiting

• Conditions: Gastroparesis in patients with chronic kidney disease.; Ondansetron; Gastroparesis; Gastric accommodation; Chronic kidney disease; Hemodialysis

• Registration Number: TCTR20240712001
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Last Update Posted: 19 August 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1) Patients with chronic kidney failure who come to use hemodialysis services at the Hemodialysis Center Faculty of Medicine Chiang Mai University (March - December 2024)
2) Have symptoms of early satiety and distension after meals. (postprandial fullness) and abnormal symptoms caused by the stomach (nausea, distension, bloating, and epigastric pain) for a period of at least 3 months.
3) Have an average total score from the Gastroparesis Cardinal Symptom Index (GCSI) questionnaire that is greater than or equal to 2 points.

Exclusion Criteria

1) Unable to reposition in a supine position.
2) Unable to communicate to answer questionnaires.
3) Ever stomach surgery or stomach cancer
4) Use drugs that reduce nausea and vomiting or drugs that increase gastrointestinal function (prokinetic drugs) during the 2 weeks before participating in the study.
5) There are restrictions on eating before hemodialysis, such as a history of low blood pressure during hemodialysis. or have excess fluid that requires hemodialysis to remove more than 4 kilograms of water
6) Unable to eat food by mouth
7) Have nausea and vomiting and cannot eat.
8) No water or food for less than 6 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) 2 Weeks PAGI-SYM questionnaire

Secondary Outcome Measures

Name	Time	Method
Gastric expansion (Proximal stomach and Distal stomach) 2 Weeks Ultrasound,Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life 2 Weeks PAGI-QOL questionnaire