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

December 21, 2022 updated by: Centre Hospitalier Universitaire de Nīmes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1680

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Alès, France
        • Recruiting
        • CH Alès Cévennes
        • Contact:
        • Principal Investigator:
          • Sad Gaizi
        • Sub-Investigator:
          • Florent Broussous
        • Sub-Investigator:
          • Dominique Bastide
        • Sub-Investigator:
          • Serge Sirvain
        • Sub-Investigator:
          • Jonathan Bibot
        • Sub-Investigator:
          • Thibaut Fraisse
        • Sub-Investigator:
          • Patrice Ray
        • Sub-Investigator:
          • Hicham Mouyazek
        • Sub-Investigator:
          • Sophie Marty
      • Bagnols-sur-Cèze, France
        • Recruiting
        • CH Bagnols-sur-Cèze
        • Contact:
        • Principal Investigator:
          • Jean-Michel Courrege
        • Sub-Investigator:
          • Ana Benoit
        • Sub-Investigator:
          • Dominique Gnonko
        • Sub-Investigator:
          • Rémy Torrogressa
        • Sub-Investigator:
          • Andrea-Cristina Favre Varadi
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes
        • Principal Investigator:
          • Olivier Moranne
        • Sub-Investigator:
          • Clarisse Roux-Marson
        • Sub-Investigator:
          • Romain Genregrandpierre
        • Sub-Investigator:
          • Cédric Leguillou
        • Sub-Investigator:
          • Guillaume Cayla
        • Sub-Investigator:
          • Eric Jourdan
        • Sub-Investigator:
          • Valérie Ray
        • Sub-Investigator:
          • Nadine Houede

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard strategy
Experimental: Warning KD strategy
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 Months
Information taken from national database
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Need for renal support
Time Frame: 12 Months
yes / no. Information available in the SNDS database and the REIN register.
12 Months
Mortality
Time Frame: 30 days
Information taken from national database
30 days
Emergency start of renal support management
Time Frame: 12 Months
Yes/no with exact date noted if yes. Information available in the REIN register
12 Months
Oriented of patient towards autonomous support techniques
Time Frame: 12 Months
Yes/no. Information available in the REIN register
12 Months
Which autonomous support techniques used
Time Frame: 12 Months
renal transplant or home dialysis
12 Months
Use of an arteriovenous fistula during the first session
Time Frame: 12 Months
Yes/no
12 Months
Duration of initial hospitalization
Time Frame: 12 Months
Days
12 Months
Duration of rehospitalizations
Time Frame: 12 Months
Days
12 Months
Causes of rehospitalizations
Time Frame: 12 Months
Information taken from SNDS database
12 Months
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
12 Months
Rate of patients with at least one inappropriate drug prescription for renal function
Time Frame: Inclusion
Inclusion
Rate of patients with at least one inappropriate drug prescription for renal function
Time Frame: 3 Months
3 Months
Rate of patients with at least one inappropriate drug prescription for renal function
Time Frame: 12 Months
12 Months
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time Frame: Inclusion
Inclusion
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time Frame: 3 Months
3 Months
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time Frame: 12 Months
12 Months
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
12 Months
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
12 Months
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
end of the interventional strategy phase (minimum 3 months, maximum 12 months)
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
end of the interventional strategy phase (minimum 3 months, maximum 12 months)
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
12 Months
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
end of the interventional strategy phase (minimum 3 months, maximum 12 months)
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
12 months
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
Over the study - maximum 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Moranne, CHU Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREPS/2019/OM-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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