Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust (WARNING KD)
Primary Purpose
Acute Kidney Injury, Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
WARNING KD
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- The patient or their representative must have given their free and informed consent oral consent
- The patient must be a member or beneficiary of a health insurance plan
- Patient living in the Gard, France
Patient with abnormal dose:
- Severe grade 4 or 5 CKD suspected in front of a GFR <30 mL / min / 1.73m2 persisting during hospitalization.
- Acute kidney injury > stage 1 defined by an increase in serum creatinine of at least 100% in less than 7 days or a threshold greater than 354 µmol / l.
Exclusion Criteria:
- The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
- It is impossible to give the subject or their representative informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding.
- Patient unable to express consent
- Patient with Stage 1 Acute kidney injury defined by an increase in serum creatinine of more than 26 µmol / l in less than 48 hours or a 50% increase in serum creatinine within 7 days.
Patient with stage 1 to 3 CKD (glomerular filtration rate (GFR)> 30 mL / min / 1.73m2)
- Palliative/end-of-life patients
- Patients who died within 72 hours of receiving the signal
- Patients hospitalized in nephrology after an emergency room visit only
- Patients under guardianship.
Sites / Locations
- CH Alès CévennesRecruiting
- CH Bagnols-sur-CèzeRecruiting
- CHU de NîmesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard strategy
Warning KD strategy
Arm Description
Outcomes
Primary Outcome Measures
Mortality
Information taken from national database
Secondary Outcome Measures
Need for renal support
yes / no. Information available in the SNDS database and the REIN register.
Mortality
Information taken from national database
Emergency start of renal support management
Yes/no with exact date noted if yes. Information available in the REIN register
Oriented of patient towards autonomous support techniques
Yes/no. Information available in the REIN register
Which autonomous support techniques used
renal transplant or home dialysis
Use of an arteriovenous fistula during the first session
Yes/no
Duration of initial hospitalization
Days
Duration of rehospitalizations
Days
Causes of rehospitalizations
Information taken from SNDS database
The rate of patients with stage ≥4 CKD followed by a nephrologist
Data-collection via the medical file on visit(s) to the nephrologist during hospitalization; after discharge from hospital via data collected in the SNDS database
Rate of patients with at least one inappropriate drug prescription for renal function
Rate of patients with at least one inappropriate drug prescription for renal function
Rate of patients with at least one inappropriate drug prescription for renal function
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Estimation of the incremental cost-efficiency ratio
ratio of la difference in cost and the difference in life expectancy between the two strategies
National scale estimation of costs avoided
Total costs of healthcare consumption and the cost of setting up the device in the two management strategies
Evaluation of the satisfaction carers of patients in the interventional group during hospitalization
6-item custom questionnaire on 5-point Likert scale with free comment section
Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization
5-item custom questionnaire on 5-point Likert scale with free comment section
Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization
5-item custom questionnaire on 5-point Likert scale with free comment section
Evaluation of patient satisfaction of patients in the interventional group
3-item custom questionnaire on 5-point Likert scale free comment section
Evaluation of patient satisfaction of patients in the interventional group
3-item custom questionnaire on 5-point Likert scale free comment section
Evaluate the implementation of the "WARNING KD" management model at individual facilities according to the Template for Intervention Description and Replication (TIDieR) checklist.
12-item checklist
Full Information
NCT ID
NCT05033652
First Posted
July 27, 2021
Last Updated
December 21, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT05033652
Brief Title
Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
Acronym
WARNING KD
Official Title
Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
December 16, 2023 (Anticipated)
Study Completion Date
December 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Kidney disease in its chronic or acute form shares many risk factors for initiation, progression and prognosis with an increase in morbidity and mortality, the length of hospitalization and the cost associated with stages of increasing severity. Its overall estimated prevalence in the general population is 13% and 0.5% from stage 4, for which referral to a nephrologist is recommended to reduce mortality, slow progression of renal disease and better prepare for treatment by renal replacement. Acute kidney injury (AKI) is defined as a sudden increase in serum creatinine (Scr) with a prognostic classification of increasing severity. The population with chronic kidney disease (CKD) is often hospitalized and is frequently complicated by AKI, however CKD is asymptomatic for a long time, requiring structure screening in populations at risk.
Performing Scr assays during hospitalization is an opportunity to screen patients with severe CRD or ARI requiring specialized treatment during and after hospitalization. A nephrological opinion is recommended for patients with severe CKD and AKI.
Based on preliminary studies "MRC GARD" (NCT02938611) and "ARI TARGET" (NCT03192189), the study investigators identified the frequency of patients with increased Scr corresponding to stages ≥4 of CKD and to stage1b of ARI during their hospitalization. They found that 50% of patients hospitalized with a severe AKI had a CKD prior to their hospitalization.
The use of dosages of Scr during hospitalization has been studied for AKI but without targeting high-risk subgroups and with discordant results. The study investigators plan to carry out a pragmatic study to show that an intervention combining alerts with Scr dosage to detect severe forms of CRD and AKI during hospitalization associated with the systematic intervention of a specialized dedicated team associating nephrologist and pharmacist to the scale of a GHT will improve patient and renal survival 1 year after screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Chronic Kidney Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Cluster step wedge
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1680 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard strategy
Arm Type
No Intervention
Arm Title
Warning KD strategy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
WARNING KD
Intervention Description
Within 48h of detecting an abnormal creatinemia value (GFR<30 or AKIN2 and AKIN3), the biology laboratory will communicate the patient's information to the "WARNING KD" team. This team consists of one nephrologist and one clinical pharmacist who will trigger the initial management in the department and then, if the patient has a persistant warning signal during hospitalization, define the patient's course of treatment for discharge. Patients requiring special care will be oriented towards a nephrologist and the patient's GP will be alerted to the benefit of addressing the patient to a nephrologist for multidisciplinary management with a therapeutic project according to the recommendations for good therapeutic practices.
Primary Outcome Measure Information:
Title
Mortality
Description
Information taken from national database
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Need for renal support
Description
yes / no. Information available in the SNDS database and the REIN register.
Time Frame
12 Months
Title
Mortality
Description
Information taken from national database
Time Frame
30 days
Title
Emergency start of renal support management
Description
Yes/no with exact date noted if yes. Information available in the REIN register
Time Frame
12 Months
Title
Oriented of patient towards autonomous support techniques
Description
Yes/no. Information available in the REIN register
Time Frame
12 Months
Title
Which autonomous support techniques used
Description
renal transplant or home dialysis
Time Frame
12 Months
Title
Use of an arteriovenous fistula during the first session
Description
Yes/no
Time Frame
12 Months
Title
Duration of initial hospitalization
Description
Days
Time Frame
12 Months
Title
Duration of rehospitalizations
Description
Days
Time Frame
12 Months
Title
Causes of rehospitalizations
Description
Information taken from SNDS database
Time Frame
12 Months
Title
The rate of patients with stage ≥4 CKD followed by a nephrologist
Description
Data-collection via the medical file on visit(s) to the nephrologist during hospitalization; after discharge from hospital via data collected in the SNDS database
Time Frame
12 Months
Title
Rate of patients with at least one inappropriate drug prescription for renal function
Time Frame
Inclusion
Title
Rate of patients with at least one inappropriate drug prescription for renal function
Time Frame
3 Months
Title
Rate of patients with at least one inappropriate drug prescription for renal function
Time Frame
12 Months
Title
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time Frame
Inclusion
Title
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time Frame
3 Months
Title
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time Frame
12 Months
Title
Estimation of the incremental cost-efficiency ratio
Description
ratio of la difference in cost and the difference in life expectancy between the two strategies
Time Frame
12 Months
Title
National scale estimation of costs avoided
Description
Total costs of healthcare consumption and the cost of setting up the device in the two management strategies
Time Frame
12 Months
Title
Evaluation of the satisfaction carers of patients in the interventional group during hospitalization
Description
6-item custom questionnaire on 5-point Likert scale with free comment section
Time Frame
end of the interventional strategy phase (minimum 3 months, maximum 12 months)
Title
Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization
Description
5-item custom questionnaire on 5-point Likert scale with free comment section
Time Frame
end of the interventional strategy phase (minimum 3 months, maximum 12 months)
Title
Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization
Description
5-item custom questionnaire on 5-point Likert scale with free comment section
Time Frame
12 Months
Title
Evaluation of patient satisfaction of patients in the interventional group
Description
3-item custom questionnaire on 5-point Likert scale free comment section
Time Frame
end of the interventional strategy phase (minimum 3 months, maximum 12 months)
Title
Evaluation of patient satisfaction of patients in the interventional group
Description
3-item custom questionnaire on 5-point Likert scale free comment section
Time Frame
12 months
Title
Evaluate the implementation of the "WARNING KD" management model at individual facilities according to the Template for Intervention Description and Replication (TIDieR) checklist.
Description
12-item checklist
Time Frame
Over the study - maximum 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient or their representative must have given their free and informed consent oral consent
The patient must be a member or beneficiary of a health insurance plan
Patient living in the Gard, France
Patient with abnormal dose:
Severe grade 4 or 5 CKD suspected in front of a GFR <30 mL / min / 1.73m2 persisting during hospitalization.
Acute kidney injury > stage 1 defined by an increase in serum creatinine of at least 100% in less than 7 days or a threshold greater than 354 µmol / l.
Exclusion Criteria:
The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
It is impossible to give the subject or their representative informed information
The patient is under safeguard of justice or state guardianship
Patient is pregnant, parturient or breastfeeding.
Patient unable to express consent
Patient with Stage 1 Acute kidney injury defined by an increase in serum creatinine of more than 26 µmol / l in less than 48 hours or a 50% increase in serum creatinine within 7 days.
Patient with stage 1 to 3 CKD (glomerular filtration rate (GFR)> 30 mL / min / 1.73m2)
Palliative/end-of-life patients
Patients who died within 72 hours of receiving the signal
Patients hospitalized in nephrology after an emergency room visit only
Patients under guardianship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Moranne
Phone
04.66.68.31.49
Email
olivier.moranne@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Moranne
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Alès Cévennes
City
Alès
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sad Gaizi
Phone
04.66.78.32.03
Email
dr.gaizi@ch-ales.fr
First Name & Middle Initial & Last Name & Degree
Sad Gaizi
First Name & Middle Initial & Last Name & Degree
Florent Broussous
First Name & Middle Initial & Last Name & Degree
Dominique Bastide
First Name & Middle Initial & Last Name & Degree
Serge Sirvain
First Name & Middle Initial & Last Name & Degree
Jonathan Bibot
First Name & Middle Initial & Last Name & Degree
Thibaut Fraisse
First Name & Middle Initial & Last Name & Degree
Patrice Ray
First Name & Middle Initial & Last Name & Degree
Hicham Mouyazek
First Name & Middle Initial & Last Name & Degree
Sophie Marty
Facility Name
CH Bagnols-sur-Cèze
City
Bagnols-sur-Cèze
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Courrege
Phone
04.66.79.10.11
Email
jmcourrege@ch-bagnolssurceze.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel Courrege
First Name & Middle Initial & Last Name & Degree
Ana Benoit
First Name & Middle Initial & Last Name & Degree
Dominique Gnonko
First Name & Middle Initial & Last Name & Degree
Rémy Torrogressa
First Name & Middle Initial & Last Name & Degree
Andrea-Cristina Favre Varadi
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Olivier Moranne
First Name & Middle Initial & Last Name & Degree
Clarisse Roux-Marson
First Name & Middle Initial & Last Name & Degree
Romain Genregrandpierre
First Name & Middle Initial & Last Name & Degree
Cédric Leguillou
First Name & Middle Initial & Last Name & Degree
Guillaume Cayla
First Name & Middle Initial & Last Name & Degree
Philippe Pouderoux
First Name & Middle Initial & Last Name & Degree
Anne-Marie Guedj
First Name & Middle Initial & Last Name & Degree
Eric Jourdan
First Name & Middle Initial & Last Name & Degree
Valérie Ray
First Name & Middle Initial & Last Name & Degree
Nadine Houede
First Name & Middle Initial & Last Name & Degree
Pascal Kouyoumdjian
First Name & Middle Initial & Last Name & Degree
Stéphane Droupy
First Name & Middle Initial & Last Name & Degree
Serge Lumbroso
12. IPD Sharing Statement
Learn more about this trial
Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
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