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Impact of Specialised Renal Care in Patients With Chronic Kidney Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00929760
Acronym
IMPLICATE
Enrollment
242
Registered
2009-06-29
Start date
2009-06-30
Completion date
2019-08-31
Last updated
2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney disease, Nephrologists, Primary Care, Death, Renal Replacement Therapy, Specialised renal care

Brief 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.

Interventions

BEHAVIORALspecialised 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.

Sponsors

Schweizerische Nierenliga
CollaboratorUNKNOWN
Patrick Saudan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary (composite): death, and hospitalisation24 months after enrollmentdeath and emergency hospitalisation during the following 2 years afterr andomisation

Secondary

MeasureTime frameDescription
Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life24 months after enrollmentcf title

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026