Association of Survival in Impact of Ultrafiltration Rate... | NCT03471299

Studies
Association of Survival in Impact of Ultrafiltration Rates in Hemodialysis Patients

NCT03471299

Sponsor

University of Hyogo

Status

Completed

Last Update Posted

Mar 20, 2018Actual

Enrollment

759Actual

Phase

Not provided

Conditions

Hemodialysis

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Feb 1, 2018Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

Mar 13, 2018

First Submission Date that Met QC Criteria

Mar 13, 2018

First Posted Date

Mar 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2018

Last Update Posted Date

Mar 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study assesses retrospectively the association of mortality on UFR assessments in our study population undergoing HD.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

759Actual

Measure	Description	Time Frame
Ultrafiltration rate (ml/hr/kg)		7 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with stable undergoing hemodialysis for >1 year.

Exclusion Criteria:

Patients with combined therapy with peritoneal dialysis and HD. Patients without records of laboratory investigations during this period. Patients with transferred hospital and those lost to follow-up.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

In this study, 759 patients who had undergone maintenance HD for >1 year at Tojinkai Hospital, kyoto, Japan. The present study examined data from all individual with regular thrice weekly maintenance HD treatment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuko Mizuno-Matsumoto, Ph.D	Graduate School of Applied Informatics, University of Hyogo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graduate School of Applied Informatics, University of Hyogo		Kobe	Hyōgo	650-0047	Japan