NCT05860491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 8, 2023

Last Update Submit

May 8, 2023

Conditions

HyperkalemiaHemolysis

Outcome Measures

Primary Outcomes (1)

  • Dietary fiber intake

    Dietary fiber intake

    3 day

Study Arms (2)

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

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

Interventions

dietary fiberOTHER

Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia

patients with pre-dialysis hyperkalemiapatients without pre-dialysis hyperkalemia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing hemodialysis

You may qualify if:

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

You may not qualify if:

  • 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；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

HyperkalemiaHemolysis

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Yang Li, Master

    Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 16, 2023

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

CN(1)