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Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit

NCT03282409 — Active not recruiting, 425 participants, Assistance Publique - Hôpitaux de Paris

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RegistryNCT03282409, acronym PREDICT
StatusActive not recruiting
Study typeObservational
Enrollment425 (Actual)
SponsorAssistance Publique - Hôpitaux de Paris (Other)
ConditionsAcute Kidney Injury, Chronic Renal Disease
Datesstart 2018-04-26, primary completion 2025-04-01 (estimated), completion 2025-05-01 (estimated), first posted 2017-09-14, last updated 2025-04-06
Locations1 site in France

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-Summary

The study aims to develop and validate a prediction score of chronic renal disease occurrence within 3 years after ICU discharge in patients who suffered an acute kidney failure during ICU stay and recovered normal renal function at 90 days following their discharge.

The primary study outcome is the incidence of chronic renal disease within the first 3 years after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.

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+Detailed description

As second objectives, the study aims to:

* Evaluate the GFR decline in patients who had an underlying chronic kidney disease.
* Evaluate factors associated with a persistent decreased GFR at day-90.
* Characterization the clinical and biological phenotype of chronic renal disease in these patients.
* Evaluate treatments provided to these patients according to CKD occurence.
* Evaluate the rate of cardiovascular and thrombo-embolic morbidity-mortality.
* Assess the quality of life every year for 3 years.
* Evaluate the medico-economic burden of CKD.

+Outcome measures

Primary outcomes

  • Incidence of chronic kidney disease [At 3 years]: Incidence of chronic kidney disease defined by a decreased glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.

Secondary outcomes

  • Progression of chronic renal disease defined by the slope of GFR decline [At 3 years]: For patients who have chronic renal disease history and developped an acute kidney failure during ICU stay, progression of chronic renal disease defined by a GFR decline greater than 30% at 3 years.
  • Progression of the proteinuria [At 3 years]: Evolution of urinary protein to creatinine ratio (mg/mmol).
  • Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation [At 3 years]: For patients who have chronic renal disease history and developped an acute kidney failure during ICU stay, progression of chronic renal disease defined by need to dialysis, or need a renal transplantation, and GFR < 15mL/minute/1.73m2.
  • Occurrence of cardiovascular events and thromboembolic events [At 3 years]: Cardiovascular events include acute coronary syndrome, ischemic stroke, peripheral artery disease, ventricular rhythm disorder and sudden death. Thromboembolic events included deep vein thrombosis and pulmonary embolism.
  • All-cause mortality [At 3 years]: All-cause mortality and cardiovascular cause mortality
  • Quality of life assessment [At the end of 1 year]: Assessment of quality of life of patients by the scale KDQOL-SF-12. The SF-12 is a short form that includes Items 1-12 as generic core of kidney Disease Quality of Life Instrument (KDQOL).
  • Quality of life assessment [At the end of 1 year]: Assessment of quality of life of patients by the scale EQ-5D-5L. The EQ-5D-5L questionnaire consists the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state.
  • Cost [At 3 years]: Costs related to medical care

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patient ⩾ 18 years;
* Patient suffering an acute kidney injury (defined by AKIN score ⩾1) during ICU stay;
* Patient discharged alive from the ICU;
* Patient's signed consent obtained;
* Patient covered by a healthcare insurance.

Exclusion Criteria:

* Pregnant or breastfeeding woman;
* SOFA score < 1 (except for kidney assessment) at time of ICU admission;
* End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU admission;
* Patient treated with dialysis at ICU discharge;
* Immunosuppressive treatment prior to ICU admission;
* Patient under legal incapacity (tutor or guardian protection);
* Being unable to follow-up of the study;
* Life expectancy expected shorter than 90 days;
* Refusal to participate in the study;
* Patient's main address is outside of Il de France region for the centers in this region;
* Patient < 18 years;
* Patient not affiliated to national social security scheme;
* Patient deprived of liberty by judicial measure.

+Locations (1)

FacilityCityCountryStatus
Intensive care unit, Ambroise Pare HospitalBoulogne-Billancourt, Hauts-de-seineFrance

+Publications

  • Results publication: de Roquetaillade C, Durand M, Beaucote V, Guillemin J, Chadjichristos CE, Roquilly A, Chousterman BG. Progression of Kidney Fibrosis after Sepsis: Underestimated Role of Resident Macrophages and Recruited Monocytes. J Am Soc Nephrol. 2025 Mar 28;36(7):1417-1427. doi: 10.1681/ASN.0000000712. PMID 40152940
  • Results publication: Geri G, Stengel B, Jacquelinet C, Aegerter P, Massy ZA, Vieillard-Baron A; PREDICT investigators. Prediction of chronic kidney disease after acute kidney injury in ICU patients: study protocol for the PREDICT multicenter prospective observational study. Ann Intensive Care. 2018 Jul 6;8(1):77. doi: 10.1186/s13613-018-0421-7. PMID 29980878

+Investigators

My Notes