Association Between Dose Dialysis by Kt and Mortality | NCT01932853

Studies
Association Between Dose Dialysis by Kt and Mortality

NCT01932853

Sponsor

NephroCare Spain

Status

Completed

Last Update Posted

Jul 13, 2016Estimated

Enrollment

6,129Actual

Phase

Not provided

Conditions

End Stage Renal Disease
Hemodialysis Patients

Interventions

Not provided

Countries

Spain

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

Oct 2015

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

Oct 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Aug 27, 2013

First Posted Date

Aug 30, 2013Estimated

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

Jul 12, 2016

Last Update Posted Date

Jul 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit.

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

6,129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemodialysis patients		Patients > 18y hemodialysis for at least 6 months at any center of Spain Fresenius Medical Care (FMC) meeting the inclusion criteria.

Interventions

Not provided

Measure	Description	Time Frame
Mortality		two years

Measure	Description	Time Frame
Hospitalization		two years

Measure	Description	Time Frame
Mortality and hospitalization cause		two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years old
> six months on hemodialysis
Receiving 3 sessions of dialysis per week
Having 5 or more valid measures of Kt during the month

Exclusion Criteria:

active chronic inflammatory diseases
Liver cirrhosis
Neoplasms
Chronic immunosuppression or use of anti-inflammatory

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study subjects:

Patients> 18 years in hemodialysis treatment at any FMC center of Spain that meet the inclusion criteria.

Data will be collected according to clinical practice and patients will be categorized according to their dose of Kt, along the two years of the study. Will seek the association of dialysis dose with mortality and hospitalization

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francesc Maduell, MD, Ph	Servei Nefrologia, ICNU, Hospital Clínic.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NephroCare Spain		Madrid	Madrid	28042	Spain

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided