Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust (WARNING KD)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Acute Kidney Injury
• Intervention / Treatment: Other: WARNING KD

• Study Type: Interventional
• Enrollment (Anticipated): 1680
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier Moranne; Phone Number: 04.66.68.31.49; Email: olivier.moranne@chu-nimes.fr

Study Locations

• France
  • Alès, France
    • Recruiting
    • CH Alès Cévennes
    • Contact: Sad Gaizi; Phone Number: 04.66.78.32.03; Email: dr.gaizi@ch-ales.fr
    • Principal Investigator: Sad Gaizi
    • Sub-Investigator: Florent Broussous
    • Sub-Investigator: Dominique Bastide
    • Sub-Investigator: Serge Sirvain
    • Sub-Investigator: Jonathan Bibot
    • Sub-Investigator: Thibaut Fraisse
    • Sub-Investigator: Patrice Ray
    • Sub-Investigator: Hicham Mouyazek
    • Sub-Investigator: Sophie Marty
  • Bagnols-sur-Cèze, France
    • Recruiting
    • CH Bagnols-sur-Cèze
    • Contact: Jean-Michel Courrege; Phone Number: 04.66.79.10.11; Email: jmcourrege@ch-bagnolssurceze.fr
    • Principal Investigator: Jean-Michel Courrege
    • Sub-Investigator: Ana Benoit
    • Sub-Investigator: Dominique Gnonko
    • Sub-Investigator: Rémy Torrogressa
    • Sub-Investigator: Andrea-Cristina Favre Varadi
  • Nîmes, France
    • Recruiting
    • CHU de Nîmes
    • Principal Investigator: Olivier Moranne
    • Sub-Investigator: Clarisse Roux-Marson
    • Sub-Investigator: Romain Genregrandpierre
    • Sub-Investigator: Cédric Leguillou
    • Sub-Investigator: Guillaume Cayla
    • Sub-Investigator: Eric Jourdan
    • Sub-Investigator: Valérie Ray
    • Sub-Investigator: Nadine Houede

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard strategy
Experimental: Warning KD strategy	Other: WARNING KD; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Information taken from national database	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for renal support	yes / no. Information available in the SNDS database and the REIN register.	12 Months
Mortality	Information taken from national database	30 days
Emergency start of renal support management	Yes/no with exact date noted if yes. Information available in the REIN register	12 Months
Oriented of patient towards autonomous support techniques	Yes/no. Information available in the REIN register	12 Months
Which autonomous support techniques used	renal transplant or home dialysis	12 Months
Use of an arteriovenous fistula during the first session	Yes/no	12 Months
Duration of initial hospitalization	Days	12 Months
Duration of rehospitalizations	Days	12 Months
Causes of rehospitalizations	Information taken from SNDS database	12 Months
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	12 Months
Rate of patients with at least one inappropriate drug prescription for renal function		Inclusion
Rate of patients with at least one inappropriate drug prescription for renal function		3 Months
Rate of patients with at least one inappropriate drug prescription for renal function		12 Months
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications		Inclusion
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications		3 Months
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications		12 Months
Estimation of the incremental cost-efficiency ratio	ratio of la difference in cost and the difference in life expectancy between the two strategies	12 Months
National scale estimation of costs avoided	Total costs of healthcare consumption and the cost of setting up the device in the two management strategies	12 Months
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	end of the interventional strategy phase (minimum 3 months, maximum 12 months)
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	end of the interventional strategy phase (minimum 3 months, maximum 12 months)
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	12 Months
Evaluation of patient satisfaction of patients in the interventional group	3-item custom questionnaire on 5-point Likert scale free comment section	end of the interventional strategy phase (minimum 3 months, maximum 12 months)
Evaluation of patient satisfaction of patients in the interventional group	3-item custom questionnaire on 5-point Likert scale free comment section	12 months
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	Over the study - maximum 2 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Olivier Moranne, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Anticipated): December 16, 2023
• Study Completion (Anticipated): December 16, 2024

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury
• Other Study ID Numbers: PREPS/2019/OM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No