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AQP-1 Polymorphism on Fluid Status in Hemodialysis Patients

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05275387
Collaborator
(none)
250
Enrollment
1
Location
29
Anticipated Duration (Days)
262.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: observational study, no intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
the Effect of AQP-1 Polymorphism on Fluid Status of Hemodialysis Patients
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Outcome Measures

Primary Outcome Measures

  1. The total ultrafiltration volume in mls from hemodialysis for the whole week of the recruitment [up to 12 weeks]

    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.)

Secondary Outcome Measures

  1. The total weight gain in kgs of each HD section of the enrollment [up to 12 weeks]

    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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renji Hospital Shanghai Shanghai China 201204

Sponsors and Collaborators

  • RenJi Hospital

Investigators

  • Principal Investigator: Zanzhe Yu, PhD, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zanzhe Yu, Prinical Inverstigator, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT05275387
Other Study ID Numbers:
  • KY2021-149-B
First Posted:
Mar 11, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
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
Keywords provided by Zanzhe Yu, Prinical Inverstigator, RenJi Hospital
AQP1
fluid status
Additional relevant MeSH terms:
Kidney Failure, Chronic

Study Results

No Results Posted as of May 26, 2022