Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date July 31, 2017
First Posted Date September 14, 2017
Last Update Posted Date July 2, 2019
Actual Study Start Date April 26, 2018
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03282409 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2019)
  • 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.
  • Progression of the proteinuria [ Time Frame: 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 [ 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.
  • 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.
  • All-cause mortality [ Time Frame: At 3 years ]
    All-cause mortality and cardiovascular cause mortality
  • 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).
  • 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.
  • Cost [ Time Frame: At 3 years ]
    Costs related to medical care
Original Secondary Outcome Measures
 (submitted: September 11, 2017)
  • 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 GFR ≤15 mL/minute/1.73m2.
  • Progression of chronic renal disease defined by the proteinuria [ Time Frame: At 3 years ]
    Cytobacteriogical testing of urine
  • 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.
  • 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.
  • All-cause mortality [ Time Frame: At 3 years ]
    All-cause mortality and cardiovascular cause mortality
  • Quality of life [ Time Frame: At the end of 1 year ]
    Evaluation of quality of life of patients by the scale KDQOL-SF-12
  • Quality of life [ Time Frame: At the end of 1 year ]
    Evaluation of quality of life of patients by the scale EQD-5L
  • Cost [ Time Frame: At 3 years ]
    Costs related to medical care
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit
Official Title Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit
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.

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient with acute kidney injury during ICU stay
Condition
  • Acute Kidney Injury
  • Chronic Renal Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 11, 2017)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03282409
Other Study ID Numbers AOR16089
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
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
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2019