Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention Du… (NCT05033652) | Clinical Trial Compass
CompletedNot Applicable
Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
France1,179 participantsStarted 2022-08-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether screening for kidney disease during a hospital stay — paired with a specialized intervention — actually reduced mortality. Can you tell me what the screening process involved and whether findings from this type of study might change how my kidney health is monitored if I'm admitted to hospital?
2The trial studied both acute kidney injury and chronic kidney disease in a hospital setting. Given my own situation, which of these conditions is most relevant to me, and would the kind of specialized intervention tested here be something my care team would consider?
3Since this trial is now completed, have any results been published or shared that you're aware of, and do the findings suggest the screening approach made a meaningful difference in survival outcomes?
4This study was conducted within a single territorial hospital trust, which can affect how broadly the results apply. Do you think the approach they tested would be relevant to the care I'd receive at our hospital, or are there differences in how kidney disease is managed here?
5If early screening and specialized intervention during hospitalization was the focus of this trial, is there anything I should be doing now — before any potential hospital stay — to protect my kidney health and make sure a problem would be caught quickly if it developed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.