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Completed

NCT Number: NCT05033652

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Alès Cévennes, Alès, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Mortality

    Time frame: 12 Months

    Information taken from national database

Secondary outcomes

  1. Need for renal support

    Time frame: 12 Months

    yes / no. Information available in the SNDS database and the REIN register.

  2. Mortality

    Time frame: 30 days

    Information taken from national database

  3. Emergency start of renal support management

    Time frame: 12 Months

    Yes/no with exact date noted if yes. Information available in the REIN register

  4. Oriented of patient towards autonomous support techniques

    Time frame: 12 Months

    Yes/no. Information available in the REIN register

  5. Which autonomous support techniques used

    Time frame: 12 Months

    renal transplant or home dialysis

  6. Use of an arteriovenous fistula during the first session

    Time frame: 12 Months

    Yes/no

  7. Duration of initial hospitalization

    Time frame: 12 Months

    Days

  8. Duration of rehospitalizations

    Time frame: 12 Months

    Days

  9. Causes of rehospitalizations

    Time frame: 12 Months

    Information taken from SNDS database

  10. The rate of patients with stage ≥4 CKD followed by a nephrologist

    Time frame: 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

  11. Rate of patients with at least one inappropriate drug prescription for renal function

    Time frame: Inclusion

  12. Rate of patients with at least one inappropriate drug prescription for renal function

    Time frame: 3 Months

  13. Rate of patients with at least one inappropriate drug prescription for renal function

    Time frame: 12 Months

  14. Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications

    Time frame: Inclusion

  15. Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications

    Time frame: 3 Months

  16. Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications

    Time frame: 12 Months

  17. Estimation of the incremental cost-efficiency ratio

    Time frame: 12 Months

    ratio of la difference in cost and the difference in life expectancy between the two strategies

  18. National scale estimation of costs avoided

    Time frame: 12 Months

    Total costs of healthcare consumption and the cost of setting up the device in the two management strategies

  19. Evaluation of the satisfaction carers of patients in the interventional group during hospitalization

    Time frame: 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

  20. Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization

    Time frame: end of the interventional strategy phase (minimum 3 months, maximum 12 months)

    5-item custom questionnaire on 5-point Likert scale with free comment section

  21. Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization

    Time frame: 12 Months

    5-item custom questionnaire on 5-point Likert scale with free comment section

  22. Evaluation of patient satisfaction of patients in the interventional group

    Time frame: end of the interventional strategy phase (minimum 3 months, maximum 12 months)

    3-item custom questionnaire on 5-point Likert scale free comment section

  23. Evaluation of patient satisfaction of patients in the interventional group

    Time frame: 12 months

    3-item custom questionnaire on 5-point Likert scale free comment section

  24. Evaluate the implementation of the "WARNING KD" management model at individual facilities according to the Template for Intervention Description and Replication (TIDieR) checklist.

    Time frame: Over the study - maximum 2 years

    12-item checklist

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: WARNING KD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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