Impact of Specialised Renal Care in Patients With Chronic Kidney Disease (IMPLICATE)

Patrick Saudan

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Behavioral: specialised renal care

Study type: Interventional

Funder types: Other

Identifiers

NCT00929760

08-226

Details and patient eligibility

About

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.

Enrollment: 242 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

nephrologists

Active Comparator group

Description:

Combined management PCP: nephrologists (at least 4 nephrology visits/year)

Treatment:

Behavioral: specialised renal care

Primary Care Physicians

Active Comparator group

Description:

Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG

Treatment:

Behavioral: specialised renal care