Chronic Kidney DiseaseICoDUNCT02878902
Impact of the Implementation of CKD Coordination Function on Dialysis Initiation Frequency in Emergency
An observational study of Chronic Kidney Disease, run by University Hospital, Caen.
Trial summary
Kidney failure is a major public health problem. REIN registry shows that 33% of patients treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care is associated with an increased risk of morbidity and mortality, with less access to off dialysis center and kidney transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Post implementation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2015
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with chronic kidney disease in our center
Who may be able to join
- Patients over 18 years with terminal chronic renal failure enrolled in the course of care
Who cannot join
- Patients under 18 years
- Patient Off Course
- Patient beginning dialysis with a method of transition
About this study
Official title: Impact of the Implementation of a Chronic Kidney Disease (CKD) Coordination Function on Dialysis Initiation Frequency in Emergency
Kidney failure is a major public health problem. REIN registry shows that 33% of patients treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care is associated with an increased risk of morbidity and mortality, with less access to off dialysis center and kidney transplant. In addition, the emergency management has an impact on the organization of health structures. The High Authority of Health in 2012 issued a "care pathway Guide" aimed "to report in this process of the multidisciplinary nature of the management and coordination of principles and procedures for the Chronic Renal failure and cooperation between professionals involved. " A function of coordinator of the Chronic Renal Disease was set up in service since May 2013. Investigators propose to carry out a study to value its impact on the start of the dialysis in emergency and hypothesize that this feature innovative in France improves the patient pathway and thus reduce support emergency frequency of ESRD.
The objective of this study is to show the improvement of the quality of care for terminally chronic renal failure patients.
This is to evaluate an experiment aimed to facilitate a complex care path. If this experiment is successful, it could form part of "advanced practice".
- Conditions
- Chronic Kidney Disease
- Being tested
- Post implementation
- Keywords
- emergency, coordination, dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post implementationOther
Patient group whose care course was organized by the nurse coordinator of chronic renal failure
| Study group | Role | What they receive |
|---|---|---|
| Before implementation | Patients registered in monitoring French registry of renal patients "Réseau Epidémiologie et Information en Néphrologie" (REIN) from January 1, 2012 to December 31, 2013 | |
| Post implementation | Patients registered in monitoring French registry of renal patients "Réseau Epidémiologie et Information en Néphrologie" (REIN) from January 1, 2014 to December 31, 2015 Receives: Other: Post implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of emergency dialysis patients beginner
The outcome is mesured at baseline (implementation of the nurse coordinator of chronic renal failure
the nurse coordinator of chronic renal failure
Baseline = implementation of this function of coordination of patients with chronic renal failure
Measured: Change of this percentage from baseline at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878902
- Sponsor's protocol ID
- 15-199
- Acronym
- ICoDU
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Implementation of a Chronic Kidney Disease (CKD) Coordination Function on Dialysis Initiation Frequency in Emergency
- ClinicalTrials.gov ID
- NCT02878902
- Acronym / sponsor ID
- ICoDU / 15-199
- Conditions
- Chronic Kidney Disease
- Keywords
- emergency, coordination, dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney failure is a major public health problem. REIN registry shows that 33% of patients treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care is associated with an increased risk of morbidity and mortality, with less access to off dialysis center and kidney transplant. In addition, the emergency management has an impact on the organization of health structures. The High Authority of Health in 2012 issued a "care pathway Guide" aimed "to report in this process of the multidisciplinary nature of the management and coordination of principles and procedures for the Chronic Renal failure and cooperation between professionals involved. " A function of coordinator of the Chronic Renal Disease was set up in service since May 2013. Investigators propose to carry out a study to value its impact on the start of the dialysis in emergency and hypothesize that this feature innovative in France improves the patient pathway and thus reduce support emergency frequency of ESRD.
The objective of this study is to show the improvement of the quality of care for terminally chronic renal failure patients.
This is to evaluate an experiment aimed to facilitate a complex care path. If this experiment is successful, it could form part of "advanced practice".
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before implementation | – | –Patients registered in monitoring French registry of renal patients "Réseau Epidémiologie et Information en Néphrologie" (REIN) from January 1, 2012 to December 31, 2013 |
| Post implementation | – | Other: Post implementationPatients registered in monitoring French registry of renal patients "Réseau Epidémiologie et Information en Néphrologie" (REIN) from January 1, 2014 to December 31, 2015 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with chronic kidney disease in our center
Key inclusion criteria (1 listed)
- Patients over 18 years with terminal chronic renal failure enrolled in the course of care
Key exclusion criteria (3 listed)
- Patients under 18 years
- Patient Off Course
- Patient beginning dialysis with a method of transition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post implementationPatient group whose care course was organized by the nurse coordinator of chronic renal failure | Other | Post implementation |
Primary outcome
Percentage of emergency dialysis patients beginner
Time frame: Change of this percentage from baseline at 2 years
The outcome is mesured at baseline (implementation of the nurse coordinator of chronic renal failure the nurse coordinator of chronic renal failure Baseline = implementation of this function of coordination of patients with chronic renal failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University Hospital, Caen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of emergency dialysis patients beginner (time frame: Change of this percentage from baseline at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.