NCT05275387

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

January 17, 2022

Last Update Submit

October 31, 2022

Conditions

End Stage Renal Disease on Dialysis

Keywords

AQP1fluid status

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The total weight gain in kgs of each HD section of the enrollment

    up to 12 weeks

Interventions

observational study, no interventionOTHER

observational study, no intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ESRD patients on maintained hemodialysis.

You may qualify if:

  • 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

You may not qualify if:

  • expected survival time less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 201204, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

total blood sample stored in local biospecimen facility

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Zanzhe Yu, PhD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zanzhe Yu, PhD

CONTACT

15901988349yuzzhrsd@163.com

Qi Lu, MD

CONTACT

68383364Luqi@renji.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinical Inverstigator

Study Record Dates

First Submitted

January 17, 2022

First Posted

March 11, 2022

Study Start

December 1, 2022

Primary Completion

January 30, 2023

Study Completion

February 28, 2023

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

CN(1)