Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
NCT ID: NCT05033652
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1680 participants
INTERVENTIONAL
2022-08-16
2024-12-16
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Standard strategy
No interventions assigned to this group
Warning KD strategy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Olivier Moranne
Role: PRINCIPAL_INVESTIGATOR
CHU Nimes
Locations
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CH Alès Cévennes
Alès, , France
CH Bagnols-sur-Cèze
Bagnols-sur-Cèze, , France
CHU de Nîmes
Nîmes, , France
Countries
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Central Contacts
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Facility Contacts
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Sad Gaizi
Role: primary
Jean-Michel Courrege
Role: primary
Anissa Megzari
Role: primary
Other Identifiers
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PREPS/2019/OM-01
Identifier Type: -
Identifier Source: org_study_id