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

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ClinicalTrials.gov Identifier: NCT03282409
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.


Condition or disease
Acute Kidney Injury Chronic Renal Disease

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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine





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


Secondary Outcome Measures :
  1. Progression of chronic renal disease defined by the slope of GFR decline [ Time Frame: 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.

  2. Progression of the proteinuria [ Time Frame: At 3 years ]
    Evolution of urinary protein to creatinine ratio (mg/mmol).

  3. Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation [ Time Frame: 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.

  4. Occurrence of cardiovascular events and thromboembolic events [ Time Frame: 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.


  5. All-cause mortality [ Time Frame: At 3 years ]
    All-cause mortality and cardiovascular cause mortality

  6. Quality of life assessment [ Time Frame: 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).

  7. Quality of life assessment [ Time Frame: 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.

  8. Cost [ Time Frame: At 3 years ]
    Costs related to medical care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with acute kidney injury during ICU stay
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282409


Contacts
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Contact: Guillaume Geri, MD +33 1 49 09 56 05 guillaume.geri@aphp.fr
Contact: Antoine Vieillard Baron, MD, PhD +33 1 49 09 56 05 antoine.vieillard-baron@aphp.fr

Locations
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France
Intensive care unit, Ambroise Pare Hospital Recruiting
Boulogne Billancourt, Hauts-de-seine, France, 92100
Contact: Guillaume Geri, MD    +331 49 09 56 05    guillaume.geri@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Guillaume Geri, MD Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
Study Director: Antoine Vieillard Baron, MD, PhD Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03282409     History of Changes
Other Study ID Numbers: AOR16089
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prediction
Chronic Renal Disease
Acute Kidney Injury

Additional relevant MeSH terms:
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Wounds and Injuries
Kidney Diseases
Acute Kidney Injury
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency