Renal FailureDETERPROFIPANCT06041737
Determination of a Profile of Patients with Renal Failure to Be Supported As a Priority in the Care Pathway in Order to Avoid Emergency Hospitalizations.
An observational study of Renal Failure, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The purpose of this study is to map the population of stage 4 and 5 kidney failure patients followed in consultation by the CHSF nephrology team and to determine the factors associated with recurrent hospitalizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- consultation
- How many people
- 405 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2023to 30 Nov 2023
- 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: Patients with renal insufficiency in stage 4 or 5 having had at least one nephrology consultation at the CHSF during the year 2020.
Who may be able to join
- Adult patients
- patients with stage 4 or 5 kidney failure who had at least one nephrology consultation during 2020.
Who cannot join
- Patients informed of the study who objected to the collection of their data.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to map the population of stage 4 and 5 kidney failure patients followed in consultation by the CHSF nephrology team and to determine the factors associated with recurrent hospitalizations.
Read the detailed description
This observational study on retrospective data does not justify a specific calculation of numbers. Over the 27-month observation period, have been identified in the department an active file of approximately 440 stage 4 or 5 chronic kidney failure patients eligible for the study.
The qualitative variables will be expressed in numbers and corresponding percentages, and compared by Fisher's exact test. Quantitative variables will be expressed by their mean and standard deviation or by their median and interquartiles, depending on their distribution. They will be compared by the Student test in the case of a normal distribution, by the Wilcoxon test otherwise.
The main outcome criterion, namely the occurrence of hospitalization during the observation period, will be analyzed using a logistic regression model. The covariates tested in the model will be :
- Age
- Gender
- Helpers among: Parent, Sibling, Child, Spouse, neighbors, friend, Social care (social security (SSC), mutual insurance or universal health coverage (CMU)
- Active, disabled, retired
- MRC Stage (4 or 5) in 2020
- Mode of entry into nephrology consultation (after hospitalization in Nephrology, attending physician, diabetologist, cardiologist, other)
- History and associated comorbidities including high blood pressure, diabetes, dyslipidemia, vascular pathologies, heart disease, sleep apnea syndrome, obesity, other chronic pathologies.
- Number of chronic pathologies of the patient
- The pathology(s) retained by the nephrologist as responsible for the kidney disease (several pathologies can be retained and reported as such)
- Number of treatments on the patient's prescription
- Treatments: hypotensive, antidiabetic, hypolipidemic, diuretic, potassium chelator, cardiac treatment, antithrombotics, others
- Number of years of follow-up in nephrology at the CHSF before the period studied.
- Status of known patients at the end of follow-up (it can be before 03/31/2022 if the patient has moved to another status before) among: consultation, dialysis (urgent or normal), transplant, death, lost to follow-up .
- Did the patient benefit from pre-dialysis information, at what Glomerular Filtration Rate (GFR) and what was his choice (peritoneal dialysis, hemodialysis or conservative treatment)
- Did the patient benefit from an arteriovenous fistula, at what GFR
- Did the patient benefit from a pre-transplant assessment
- The number of consultations by a nephrologist, in consultation or in day hospital.
- The number of consultations canceled by the patient.
- The number of consultations not honored by the patient.
- Le nombre de consultations sans bilan récent.
- The GFR at the consultation
- Unscheduled hospitalizations at the CHSF during follow-up, whether in nephrology or in another hospital department.
- The reason(s) for unscheduled hospitalizations related to renal pathology (cardiac decompensation, anemia, sodium and water overdose, acute lung edema (APO), high blood pressure (hypertension), emergency dialysis starts, renal failure acute (ARI), and ionic disorders,)
- The number of days for each hospitalization. The log-linearity of the quantitative variables will be evaluated by graphical method. In the event of non-log-linearity, the variable will be discretized according to its median or according to the inflection points of the curve. Covariates whose unadjusted Odds Ratio has a p value less than 0.20 will be retained in the multivariate model. All second-order interactions will be tested. Multicollinearity phenomena will be evaluated by measuring variance inflation factors, with a positivity threshold set at 2.5. A variable selection using a descending step-by-step method minimizing the Akaiké criterion will then be carried out. The area under the ROC curve of the final model as well as the p value of the Hosmer-Lemeshow test will be specified.
In secondary analyses, patients who were not hospitalized during the observation period will be compared to those who had 1 to 3 hospitalizations and to those who had 4 or more hospitalizations. Qualitative variables will be analyzed using Fisher's exact test. The quantitative variables will be compared by analysis of variance if its conditions of application are met, by the Kruskal-Wallis test otherwise. In the event of significance, comparisons 2 by 2 will be carried out, respectively by the Student test or the Wilcoxon test, with adjustment of the value of p by the Bonferroni-Holm correction in order to take account of the multiple comparisons.
All the tests will be carried out bilaterally, with a 1st type risk set at 5%. The analysis will be performed using R software (version 4.3.1 © 2023 The R Foundation for Statistical Computing).
Management of missing data:
no plan to replace missing data for this observational data study, the design of which in any case makes the presence of missing data in numbers unlikely, particularly concerning the main criterion.
- Conditions
- Renal Failure
- Being tested
- consultation
- Keywords
- Chronic kidney disease, Patients profile, Hospitalization profile, Advanced practice nurse, Organizational protocol
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consultationOther
nephrology consultation during 2020
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of factors associated with recurrent hospitalizations in patients followed for stage 4 or 5 Chronic Renal Failure.
characteristics of patients who have had at least one hospitalization and those who have never been hospitalized over the period from January 1, 2020 to March 31, 2022
Measured: at day 0
Secondary outcomes (2)
Mapping of the population of patients with stage IV and V renal failure followed in consultation by the CHSF nephrology team.
General and medical characteristics of patients followed at the CHSF in nephrology consultation for stage 4 or 5 CKD
Measured: at day 0
Determination of the profile(s) of stage 4 or 5 CKD patients with recurrent hospitalizations.
Comparison of patient cohorts with a single hospitalization and more than 4 hospitalizations
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start9 Oct 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine BOUHELIER, nurse, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041737
- Sponsor's protocol ID
- 2023/0023
- Acronym
- DETERPROFIPA
- Status last verified
- Nov 2024
- First submitted
- 11 Sep 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of a Profile of Patients with Renal Failure to Be Supported As a Priority in the Care Pathway in Order to Avoid Emergency Hospitalizations.
- ClinicalTrials.gov ID
- NCT06041737
- Acronym / sponsor ID
- DETERPROFIPA / 2023/0023
- Conditions
- Renal Failure
- Keywords
- Chronic kidney disease, Patients profile, Hospitalization profile, Advanced practice nurse, Organizational protocol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Sep 2023 (actual)
- 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.
The purpose of this study is to map the population of stage 4 and 5 kidney failure patients followed in consultation by the CHSF nephrology team and to determine the factors associated with recurrent hospitalizations.
Detailed description
This observational study on retrospective data does not justify a specific calculation of numbers. Over the 27-month observation period, have been identified in the department an active file of approximately 440 stage 4 or 5 chronic kidney failure patients eligible for the study.
The qualitative variables will be expressed in numbers and corresponding percentages, and compared by Fisher's exact test. Quantitative variables will be expressed by their mean and standard deviation or by their median and interquartiles, depending on their distribution. They will be compared by the Student test in the case of a normal distribution, by the Wilcoxon test otherwise.
The main outcome criterion, namely the occurrence of hospitalization during the observation period, will be analyzed using a logistic regression model. The covariates tested in the model will be :
- Age
- Gender
- Helpers among: Parent, Sibling, Child, Spouse, neighbors, friend, Social care (social security (SSC), mutual insurance or universal health coverage (CMU)
- Active, disabled, retired
- MRC Stage (4 or 5) in 2020
- Mode of entry into nephrology consultation (after hospitalization in Nephrology, attending physician, diabetologist, cardiologist, other)
- History and associated comorbidities including high blood pressure, diabetes, dyslipidemia, vascular pathologies, heart disease, sleep apnea syndrome, obesity, other chronic pathologies.
- Number of chronic pathologies of the patient
- The pathology(s) retained by the nephrologist as responsible for the kidney disease (several pathologies can be retained and reported as such)
- Number of treatments on the patient's prescription
- Treatments: hypotensive, antidiabetic, hypolipidemic, diuretic, potassium chelator, cardiac treatment, antithrombotics, others
- Number of years of follow-up in nephrology at the CHSF before the period studied.
- Status of known patients at the end of follow-up (it can be before 03/31/2022 if the patient has moved to another status before) among: consultation, dialysis (urgent or normal), transplant, death, lost to follow-up .
- Did the patient benefit from pre-dialysis information, at what Glomerular Filtration Rate (GFR) and what was his choice (peritoneal dialysis, hemodialysis or conservative treatment)
- Did the patient benefit from an arteriovenous fistula, at what GFR
- Did the patient benefit from a pre-transplant assessment
- The number of consultations by a nephrologist, in consultation or in day hospital.
- The number of consultations canceled by the patient.
- The number of consultations not honored by the patient.
- Le nombre de consultations sans bilan récent.
- The GFR at the consultation
- Unscheduled hospitalizations at the CHSF during follow-up, whether in nephrology or in another hospital department.
- The reason(s) for unscheduled hospitalizations related to renal pathology (cardiac decompensation, anemia, sodium and water overdose, acute lung edema (APO), high blood pressure (hypertension), emergency dialysis starts, renal failure acute (ARI), and ionic disorders,)
- The number of days for each hospitalization. The log-linearity of the quantitative variables will be evaluated by graphical method. In the event of non-log-linearity, the variable will be discretized according to its median or according to the inflection points of the curve. Covariates whose unadjusted Odds Ratio has a p value less than 0.20 will be retained in the multivariate model. All second-order interactions will be tested. Multicollinearity phenomena will be evaluated by measuring variance inflation factors, with a positivity threshold set at 2.5. A variable selection using a descending step-by-step method minimizing the Akaiké criterion will then be carried out. The area under the ROC curve of the final model as well as the p value of the Hosmer-Lemeshow test will be specified.
In secondary analyses, patients who were not hospitalized during the observation period will be compared to those who had 1 to 3 hospitalizations and to those who had 4 or more hospitalizations. Qualitative variables will be analyzed using Fisher's exact test. The quantitative variables will be compared by analysis of variance if its conditions of application are met, by the Kruskal-Wallis test otherwise. In the event of significance, comparisons 2 by 2 will be carried out, respectively by the Student test or the Wilcoxon test, with adjustment of the value of p by the Bonferroni-Holm correction in order to take account of the multiple comparisons.
All the tests will be carried out bilaterally, with a 1st type risk set at 5%. The analysis will be performed using R software (version 4.3.1 © 2023 The R Foundation for Statistical Computing).
Management of missing data:
no plan to replace missing data for this observational data study, the design of which in any case makes the presence of missing data in numbers unlikely, particularly concerning the main criterion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with renal insufficiency in stage 4 or 5 having had at least one nephrology consultation at the CHSF during the year 2020.
Key inclusion criteria (2 listed)
- Adult patients
- patients with stage 4 or 5 kidney failure who had at least one nephrology consultation during 2020.
Key exclusion criteria (1 listed)
- Patients informed of the study who objected to the collection of their data.
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 |
|---|---|---|
| consultationnephrology consultation during 2020 | Other | – |
Primary outcome
Determination of factors associated with recurrent hospitalizations in patients followed for stage 4 or 5 Chronic Renal Failure.
Time frame: at day 0
characteristics of patients who have had at least one hospitalization and those who have never been hospitalized over the period from January 1, 2020 to March 31, 2022
2 secondary outcomes
Mapping of the population of patients with stage IV and V renal failure followed in consultation by the CHSF nephrology team.
Time frame: at day 0
Determination of the profile(s) of stage 4 or 5 CKD patients with recurrent hospitalizations.
Time frame: at day 0
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 26 Nov 2024.
- 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.
Christine BOUHELIER, nurse principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure, run by Centre Hospitalier Sud Francilien at 1 site in France.
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 2 inclusion and 1 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Determination of factors associated with recurrent hospitalizations in patients followed for stage 4 or 5 Chronic Renal Failure. (time frame: at day 0). 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 26 Nov 2024.