AQP-1 Polymorphism on Fluid Status in Hemodialysis Patients

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

the Effect of AQP-1 Polymorphism on Fluid Status of Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05275387
• Other study ID #: KY2021-149-B
• Status: Not yet recruiting
• Start date: December 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: October 2022
• Source: RenJi Hospital
• Contact: Zanzhe Yu, PhD
• Phone: 15901988349
• Email: yuzzhrsd[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is a cross sectional observational study. It is to investigate whether AQP-1 polymorphism has any impact on fluid status in hemodialysis patients. The long term stable HD patients in the current center will be enrolled to the study after informed consent. Blood samples will be collected for gene-typing. Fluid status including blood pressure, weekly UF and intra-dialysis body weight change will be collected through their clinical records.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: February 28, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age 18-70

• ESRD

• maintained HD

• no target weight change during the last week of entering the study and achieve target weight at the end of HD section

• informed consented

Exclusion Criteria:

• expected survival time less than 3 months

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

Other:
• observational study, no intervention
observational study, no intervention

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total ultrafiltration volume in mls from hemodialysis for the whole week of the recruitment	The ultrafiltration volume of each HD section of the enrollment week will be recorded. The total ultrafiltration volume of the week is the primary outcome measure. (In most cases, HD patients have three HD sections per week.)	up to 12 weeks
Secondary	The total weight gain in kgs of each HD section of the enrollment	The body weight gain of each HD section of the enrollment week will be recorded. The total body weight gain of the week is the secondary outcome measure. (In most cases, HD patients have three HD sections per week.)	up to 12 weeks