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NCT00929760 Clinical Trial

Impact of Specialised Renal Care in Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— IMPLICATE  

Official title:
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00929760
Other study ID # 08-226
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2009
Est. completion date August 2019

Study information
Verified date September 2009
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney disease (CKD) in order to determine the impact of specialised care by nephrologists compared to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation RRT) and c) patient satisfaction.

Recruitment information / eligibility
Status Completed
Enrollment 242
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with CKD stage 3, 4 and 5 (CCl < 40 ml/min according to abbreviated MDRD formula) aged 18-80 years old and enrolled during a hospitalization.

Exclusion Criteria:

- Patients previously known by nephrologists.

- Estimated life expectancy < 1 year

- Refusal or inability to sign writing consent

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• specialised renal care
Combined management PCP - nephrologists (at least 4 nephrology visits/year). Agreement of the PCP is required for this combined management. Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG. Requested Email or over the phone advices to PCPs will be provided by the nephrology division of HUG.

Locations
Country Name City State
Switzerland Nephrology Unit Geneva University Hospitals Geneva Geneva City

Sponsors (2)
Lead Sponsor Collaborator
Patrick Saudan Schweizerische Nierenliga

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary (composite): death, and hospitalisation death and emergency hospitalisation during the following 2 years afterr andomisation 24 months after enrollment
Secondary Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life cf title 24 months after enrollment
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