Dietary Fiber and Hyperkalemia in Dialysis Patients

• Sponsor: Qianfoshan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05860491
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 16.9

Study Details

Study Description

Brief Summary

To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia; Hemolysis	Other: dietary fiber

Detailed Description

A total of 100 MHD patients were retrospectively enrolled, including 67 males and 33 females. The daily diet was recorded by 3-day dietary recording method. The daily average dietary nutritional intake and DF intake of MHD patients were calculated by professional software. Dietary guidance and analysis were conducted according to the Expert Consensus on Nutrition in Chronic Kidney Disease (2005) and the Dietary Guidelines for Chinese Residents (2016). Of the 100 patients, 37 had hyperkalemia (serum potassium > 5.5 mmol/L) before dialysis.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: The Role of Dietary Fiber on Hyperkalemia in Hemodialysis Patients
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
patients with pre-dialysis hyperkalemia To investigate the dietary fiber intake of hemodialysis patients with pre-dialysis hyperkalemia. Use a retrospective analysis method. Analyze the relationship between dietary fiber intake and hyperkalemia.	Other: dietary fiber; Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia
patients without pre-dialysis hyperkalemia To investigate the dietary fiber intake of hemodialysis patients without pre-dialysis hyperkalemia. Use a retrospective analysis method. Analyze the relationship between dietary fiber intake and hyperkalemia.	Other: dietary fiber; Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia

Outcome Measures

Primary Outcome Measures

1. Dietary fiber intake [3 day]

   Dietary fiber intake

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-65 years old; undergoing hemodialysis at least 3months; with a certain level of education; with complete behavioral ability

Exclusion Criteria:

• In the acute phase of acute cardiovascular disease, acute cerebrovascular disease, and acute digestive system disease；Anorexia, long-term malnutrition, or dietary disorders；poor compliance；

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qianfoshan Hospital	Jinan	Shandong	China	250014

Sponsors and Collaborators

• Qianfoshan Hospital

Investigators

• Principal Investigator: Yang Li, Master, Qianfoshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yang Li, Attending physician, Qianfoshan Hospital
• ClinicalTrials.gov Identifier: NCT05860491
• Other Study ID Numbers: DF-hyperkalemia
• First Posted: May 16, 2023
• Last Update Posted: May 16, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperkalemia; Hemolysis

Study Results

No Results Posted as of May 16, 2023