Acute Kidney InjuryPREDICTNCT03282409
Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit
An observational study of Acute Kidney Injury and Chronic Renal Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Chronic Renal Disease
- How many people
- 425 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2018to May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patient with acute kidney injury during ICU stay
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Intensive care unit, Ambroise Pare Hospital
Boulogne-Billancourt, Hauts-de-seine, 92100
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Chronic Renal Disease
- Keywords
- Prediction, Chronic Renal Disease, Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic kidney disease
Incidence of chronic kidney disease defined by a decreased glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.
Measured: At 3 years
Secondary outcomes (8)
Progression of chronic renal disease defined by the slope of GFR decline
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.
Measured: At 3 years
Progression of the proteinuria
Evolution of urinary protein to creatinine ratio (mg/mmol).
Measured: At 3 years
Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation
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.
Measured: At 3 years
Occurrence of cardiovascular events and thromboembolic events
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.
Measured: At 3 years
All-cause mortality
All-cause mortality and cardiovascular cause mortality
Measured: At 3 years
Quality of life assessment
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).
Measured: At the end of 1 year
Quality of life assessment
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.
Measured: At the end of 1 year
Cost
Costs related to medical care
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start26 Apr 2018
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Geri, MD, PhD, Principal investigator, Service de Réanimation médico-chirurgicale, Hôpital Ambroise ParéAntoine Vieillard Baron, MD, PhD, Study director, Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282409
- Sponsor's protocol ID
- AOR16089
- Acronym
- PREDICT
- Status last verified
- Mar 2025
- First submitted
- 31 Jul 2017
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40152940Geri 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.
PubMed 29980878
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03282409
- Acronym / sponsor ID
- PREDICT / AOR16089
- Conditions
- Acute Kidney Injury, Chronic Renal Disease
- Keywords
- Prediction, Chronic Renal Disease, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 14 Sep 2017 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with acute kidney injury during ICU stay
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Progression of chronic renal disease defined by the slope of GFR decline
Time frame: At 3 years
Progression of the proteinuria
Time frame: At 3 years
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
Occurrence of cardiovascular events and thromboembolic events
Time frame: At 3 years
All-cause mortality
Time frame: At 3 years
Quality of life assessment
Time frame: At the end of 1 year
Quality of life assessment
Time frame: At the end of 1 year
Cost
Time frame: At 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 40152940de 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.
- Derived from this study: PubMed 29980878Geri 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.
- Individual participant dataSharing planned: No
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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.
Guillaume Geri, MD, PhD principal investigator
Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
Antoine Vieillard Baron, MD, PhD study director
Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Chronic Renal Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 5 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of chronic kidney disease (time frame: At 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282409, which also lists 2 linked publications.
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 6 Apr 2025.