Acute Kidney InjuryWARNING KDNCT05033652
Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
A study testing WARNING KD in people with Acute Kidney Injury and Chronic Kidney Diseases, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Diseases
- What is being tested?
- WARNING KD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,179 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Aug 2022to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH Alès Cévennes
Alès
CH Bagnols-sur-Cèze
Bagnols-sur-Cèze
CHU de Nîmes
Nîmes
About this study
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.
Read more
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
- Being tested
- WARNING KD
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WARNING KDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard strategy | No intervention | Not described |
| Warning KD strategy | Experimental | Not described Receives: Other: WARNING KD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Information taken from national database
Measured: 12 Months
Secondary outcomes (24)
Need for renal support
yes / no. Information available in the SNDS database and the REIN register.
Measured: 12 Months
Mortality
Information taken from national database
Measured: 30 days
Emergency start of renal support management
Yes/no with exact date noted if yes. Information available in the REIN register
Measured: 12 Months
Oriented of patient towards autonomous support techniques
Yes/no. Information available in the REIN register
Measured: 12 Months
Which autonomous support techniques used
renal transplant or home dialysis
Measured: 12 Months
Use of an arteriovenous fistula during the first session
Yes/no
Measured: 12 Months
Duration of initial hospitalization
Days
Measured: 12 Months
Duration of rehospitalizations
Days
Measured: 12 Months
Causes of rehospitalizations
Information taken from SNDS database
Measured: 12 Months
The rate of patients with stage ≥4 CKD followed by a nephrologist
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
Measured: 12 Months
Rate of patients with at least one inappropriate drug prescription for renal function
Measured: Inclusion
Rate of patients with at least one inappropriate drug prescription for renal function
Measured: 3 Months
Rate of patients with at least one inappropriate drug prescription for renal function
Measured: 12 Months
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Measured: Inclusion
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Measured: 3 Months
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Measured: 12 Months
Estimation of the incremental cost-efficiency ratio
ratio of la difference in cost and the difference in life expectancy between the two strategies
Measured: 12 Months
National scale estimation of costs avoided
Total costs of healthcare consumption and the cost of setting up the device in the two management strategies
Measured: 12 Months
Evaluation of the satisfaction carers of patients in the interventional group during hospitalization
6-item custom questionnaire on 5-point Likert scale with free comment section
Measured: 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
5-item custom questionnaire on 5-point Likert scale with free comment section
Measured: 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
5-item custom questionnaire on 5-point Likert scale with free comment section
Measured: 12 Months
Evaluation of patient satisfaction of patients in the interventional group
3-item custom questionnaire on 5-point Likert scale free comment section
Measured: end of the interventional strategy phase (minimum 3 months, maximum 12 months)
Evaluation of patient satisfaction of patients in the interventional group
3-item custom questionnaire on 5-point Likert scale free comment section
Measured: 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.
12-item checklist
Measured: Over the study - maximum 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start16 Aug 2022
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cluster step wedge
- Masking
- None (open label)
- Enrolment
- 1,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Moranne, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033652
- Sponsor's protocol ID
- PREPS/2019/OM-01
- Acronym
- WARNING KD
- Status last verified
- Jun 2026
- First submitted
- 27 Jul 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
- ClinicalTrials.gov ID
- NCT05033652
- Acronym / sponsor ID
- WARNING KD / PREPS/2019/OM-01
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,179 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster step wedge
| Arm | Type | Receives |
|---|---|---|
| Standard strategy | No intervention | – |
| Warning KD strategy | Experimental | Other: WARNING KD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WARNING KDWithin 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. | Other | Warning KD strategy |
Primary outcome
Mortality
Time frame: 12 Months
Information taken from national database
24 secondary outcomes
Need for renal support
Time frame: 12 Months
Mortality
Time frame: 30 days
Emergency start of renal support management
Time frame: 12 Months
Oriented of patient towards autonomous support techniques
Time frame: 12 Months
Which autonomous support techniques used
Time frame: 12 Months
Use of an arteriovenous fistula during the first session
Time frame: 12 Months
Duration of initial hospitalization
Time frame: 12 Months
Duration of rehospitalizations
Time frame: 12 Months
Causes of rehospitalizations
Time frame: 12 Months
The rate of patients with stage ≥4 CKD followed by a nephrologist
Time frame: 12 Months
Rate of patients with at least one inappropriate drug prescription for renal function
Time frame: Inclusion
Rate of patients with at least one inappropriate drug prescription for renal function
Time frame: 3 Months
Rate of patients with at least one inappropriate drug prescription for renal function
Time frame: 12 Months
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time frame: Inclusion
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time frame: 3 Months
Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications
Time frame: 12 Months
Estimation of the incremental cost-efficiency ratio
Time frame: 12 Months
National scale estimation of costs avoided
Time frame: 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)
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)
Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization
Time frame: 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)
Evaluation of patient satisfaction of patients in the interventional group
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Moranne principal investigator
CHU Nimes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WARNING KD in people with Acute Kidney Injury and Chronic Kidney Diseases, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.