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

NCT05033652 | Completed

• 1 other identifier: PREPS/2019/OM-01
• Study Type: interventional
• Target: 1,179
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Kidney Injury; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Mortality

  Information taken from national database

  12 Months

Secondary Outcomes (24)

• Need for renal support

  12 Months

• Mortality

  30 days

• Emergency start of renal support management

  12 Months

• Oriented of patient towards autonomous support techniques

  12 Months

• Which autonomous support techniques used

  12 Months

Study Arms (2)

Standard strategy

NO INTERVENTION

Warning KD strategy

EXPERIMENTAL

Other: WARNING KD

Interventions

WARNING KD OTHER

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.

Warning KD strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

CH Alès Cévennes

Alès, France

Location

CH Bagnols-sur-Cèze

Bagnols-sur-Cèze, France

Location

CHU de Nîmes

Nîmes, France

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Moranne

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster step wedge

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: September 5, 2021
• Study Start: August 16, 2022
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

FR (3)