AQP-1 Polymorphism on Fluid Status in Hemodialysis Patients

October 31, 2022 updated by: Zanzhe Yu, RenJi Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201204
        • RenJi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ESRD patients on maintained hemodialysis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total ultrafiltration volume in mls from hemodialysis for the whole week of the recruitment
Time Frame: 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.)
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total weight gain in kgs of each HD section of the enrollment
Time Frame: 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.)
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Zanzhe Yu, PhD, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

January 30, 2023

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2021-149-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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