Association Between Dose Dialysis by Kt and Mortality

End Stage Renal Disease Clinical Trial

Official title:

Evaluation of the Association of Dialysis Dose Obtained by Kt and Mortality in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932853
• Other study ID #: QM-RR-02
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: July 12, 2016
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: NephroCare Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6129
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis Patients
• Kidney Failure, Chronic

Locations

Country	Name	City	State
Spain	NephroCare Spain	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
NephroCare Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality and hospitalization cause		two years	No
Primary	Mortality		two years	No
Secondary	Hospitalization		two years	No