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

Not Applicable

Recruiting

• Conditions: Acute Kidney Injury; Chronic Kidney Diseases
• Interventions: Other: WARNING KD

• Registration Number: NCT05033652
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-05
• Study Start: 2022-08-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22
• Primary Completion: 2023-12-16
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1680

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Warning KD strategy	WARNING KD	-

Primary Outcome Measures

Name	Time	Method
Mortality	12 Months	Information taken from national database

Secondary Outcome Measures

Name	Time	Method
Evaluation of the satisfaction carers of patients in the interventional group during hospitalization	end of the interventional strategy phase (minimum 3 months, maximum 12 months)	6-item custom questionnaire on 5-point Likert scale with free comment section
Mortality	30 days	Information taken from national database
Emergency start of renal support management	12 Months	Yes/no with exact date noted if yes. Information available in the REIN register
Which autonomous support techniques used	12 Months	renal transplant or home dialysis
Duration of rehospitalizations	12 Months	Days
Causes of rehospitalizations	12 Months	Information taken from SNDS database
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications	12 Months
Evaluation of patient satisfaction of patients in the interventional group	12 months	3-item custom questionnaire on 5-point Likert scale free comment section
Need for renal support	12 Months	yes / no. Information available in the SNDS database and the REIN register.
Rate of patients with at least one inappropriate drug prescription for renal function	12 Months
Use of an arteriovenous fistula during the first session	12 Months	Yes/no
The rate of patients with stage ≥4 CKD followed by a nephrologist	12 Months	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
Estimation of the incremental cost-efficiency ratio	12 Months	ratio of la difference in cost and the difference in life expectancy between the two strategies
Evaluate the implementation of the "WARNING KD" management model at individual facilities according to the Template for Intervention Description and Replication (TIDieR) checklist.	Over the study - maximum 2 years	12-item checklist
Oriented of patient towards autonomous support techniques	12 Months	Yes/no. Information available in the REIN register
National scale estimation of costs avoided	12 Months	Total costs of healthcare consumption and the cost of setting up the device in the two management strategies
Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization	12 Months	5-item custom questionnaire on 5-point Likert scale with free comment section
Duration of initial hospitalization	12 Months	Days

Trial Locations

Locations (3)

CH Bagnols-sur-Cèze; 🇫🇷 Bagnols-sur-Cèze, France

CH Alès Cévennes; 🇫🇷 Alès, France

CHU de Nîmes; 🇫🇷 Nîmes, France