Clinical trial NCT05033652: Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
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
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Chronic Kidney Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 1680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster step wedge
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Mortality
timeFrame: 12 Months
Secondary outcomes:
measure: Need for renal support
timeFrame: 12 Months
measure: Mortality
timeFrame: 30 days
measure: Emergency start of renal support management
timeFrame: 12 Months
measure: Oriented of patient towards autonomous support techniques
timeFrame: 12 Months
measure: Which autonomous support techniques used
timeFrame: 12 Months
measure: Use of an arteriovenous fistula during the first session
timeFrame: 12 Months
measure: Duration of initial hospitalization
timeFrame: 12 Months
measure: Duration of rehospitalizations
timeFrame: 12 Months
measure: Causes of rehospitalizations
timeFrame: 12 Months
measure: The rate of patients with stage ≥4 CKD followed by a nephrologist
timeFrame: 12 Months
measure: Rate of patients with at least one inappropriate drug prescription for renal function
timeFrame: Inclusion
measure: Rate of patients with at least one inappropriate drug prescription for renal function
timeFrame: 3 Months
measure: Rate of patients with at least one inappropriate drug prescription for renal function
timeFrame: 12 Months
measure: Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
timeFrame: Inclusion
measure: Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
timeFrame: 3 Months
measure: Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
timeFrame: 12 Months
measure: Estimation of the incremental cost-efficiency ratio
timeFrame: 12 Months
measure: National scale estimation of costs avoided
timeFrame: 12 Months
measure: Evaluation of the satisfaction carers of patients in the interventional group during hospitalization
timeFrame: end of the interventional strategy phase (minimum 3 months, maximum 12 months)
measure: Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization
timeFrame: end of the interventional strategy phase (minimum 3 months, maximum 12 months)
measure: Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization
timeFrame: 12 Months
measure: Evaluation of patient satisfaction of patients in the interventional group
timeFrame: end of the interventional strategy phase (minimum 3 months, maximum 12 months)
measure: Evaluation of patient satisfaction of patients in the interventional group
timeFrame: 12 months
measure: Evaluate the implementation of the "WARNING KD" management model at individual facilities according to the Template for Intervention Description and Replication (TIDieR) checklist.
timeFrame: Over the study - maximum 2 years
Other outcomes:
Locations:
city: Alès
country: France
facility: CH Alès Cévennes
city: Bagnols-sur-Cèze
country: France
facility: CH Bagnols-sur-Cèze
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU Nimes
name: Olivier Moranne
role: PRINCIPAL_INVESTIGATOR
References: