Back to resultsImpact of Specialised Renal Care in Patients With Chronic Kidney Disease (IMPLICATE)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
specialised renal care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney disease, Nephrologists, Primary Care, Death, Renal Replacement Therapy, Specialised renal care
Eligibility Criteria
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
Sites / Locations
- Nephrology Unit Geneva University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
nephrologists
Primary Care Physicians
Arm Description
Combined management PCP: nephrologists (at least 4 nephrology visits/year)
Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG
Outcomes
Primary Outcome Measures
Primary (composite): death, and hospitalisation
death and emergency hospitalisation during the following 2 years afterr andomisation
Secondary Outcome Measures
Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life
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Full Information
NCT ID
NCT00929760
First Posted
June 26, 2009
Last Updated
August 13, 2019
Sponsor
Patrick Saudan
Collaborators
Schweizerische Nierenliga
1. Study Identification
Unique Protocol Identification Number
NCT00929760
Brief Title
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease
Acronym
IMPLICATE
Official Title
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Saudan
Collaborators
Schweizerische Nierenliga
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney disease, Nephrologists, Primary Care, Death, Renal Replacement Therapy, Specialised renal care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nephrologists
Arm Type
Active Comparator
Arm Description
Combined management PCP: nephrologists (at least 4 nephrology visits/year)
Arm Title
Primary Care Physicians
Arm Type
Active Comparator
Arm Description
Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG
Intervention Type
Behavioral
Intervention Name(s)
specialised renal care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary (composite): death, and hospitalisation
Description
death and emergency hospitalisation during the following 2 years afterr andomisation
Time Frame
24 months after enrollment
Secondary Outcome Measure Information:
Title
Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life
Description
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Time Frame
24 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nephrology Unit Geneva University Hospitals
City
Geneva
State/Province
Geneva City
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
32272886
Citation
Saudan P, Ponte B, Marangon N, Martinez C, Berchtold L, Jaques D, Ernandez T, de Seigneux S, Carballo S, Perneger T, Martin PY. Impact of superimposed nephrological care to guidelines-directed management by primary care physicians of patients with stable chronic kidney disease: a randomized controlled trial. BMC Nephrol. 2020 Apr 9;21(1):128. doi: 10.1186/s12882-020-01747-3.
Results Reference
derived
Learn more about this trial
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease
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