Acute Kidney InjuriesSURIANCT03302624
Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU
An observational study of Acute Kidney Injuries and Quality of Life, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown. The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injuries, Quality of Life, Chronic Kidney Disease
- How many people
- 506 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: ICU patients
Who may be able to join
- ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU stay ≥ 48h
Who cannot join
- Pregnant or nursing woman's job
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Alexandre LAUTRETTE
Didier GRUSON
About this study
Official title: A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU
Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.
The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.
Read the detailed description
Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can be enrolled in SURIA.
Patients are contacted by telephone. Investigator delivery objective and honest information. If patients accepts the study, answers will be collected.
Collected data are: creatinine serum, two surveys (quality of life and activities of daily living), date of onset of renal replacement therapy.
- Keywords
- acute kidney injury, quality of life, Renal replacement therapy, Intensive care unit
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who were included in ELVIS study | Not described |
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 in patients who had an acute kidney injury during their ICU stay and requiring an renal replacement therapy
Measured: 5 years after the first acute kidney injury requiring renal replacement therapy
Secondary outcomes (5)
severity of CKD according to the International Classification of Chronic Kidney Disease
Kidney function will be measured by creatinine serum or chronic dialysis or kidney transplantation
Measured: 5 years after the first acute kidney injury requiring renal replacement therapy
impact of the renal replacement therapy on long-term renal function
Intermittent or continuous renal replacement therapy. Data collected in the database from ELVIS study. Kidney function will be measured by creatinine serum or chronic dialysis
Measured: 5 years after the first acute kidney injury requiring renal replacement therapy
quality of life
Quality of life will be assessed with the Q5D score
Measured: 5 years after the first acute kidney injury requiring renal replacement therapy
Activities of daily living
Activities of daily living will be assessed with the Katz adjustment scales
Measured: 5 years after the first acute kidney injury requiring renal replacement therapy
Mortality
Mortality
Measured: 5 years after the first acute kidney injury requiring renal replacement therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre LAUTRETTE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302624
- Sponsor's protocol ID
- CHU-351
- Acronym
- SURIA
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soum E, Timsit JF, Ruckly S, Gruson D, Canet E, Klouche K, Argaud L, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Darmon M, Bohe J, Schwebel C, Bouadma L, Dupuis C, Souweine B, Lautrette A. Predictive factors for severe long-term chronic kidney disease after acute kidney injury requiring renal replacement therapy in critically ill patients: an ancillary study of the ELVIS randomized controlled trial. Crit Care. 2022 Nov 29;26(1):367. doi: 10.1186/s13054-022-04233-4.
PubMed 36447221
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU
- ClinicalTrials.gov ID
- NCT03302624
- Acronym / sponsor ID
- SURIA / CHU-351
- Keywords
- acute kidney injury, quality of life, Renal replacement therapy, Intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 5 Oct 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.
Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.
The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.
Detailed description
Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can be enrolled in SURIA.
Patients are contacted by telephone. Investigator delivery objective and honest information. If patients accepts the study, answers will be collected.
Collected data are: creatinine serum, two surveys (quality of life and activities of daily living), date of onset of renal replacement therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who were included in ELVIS study | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (1 listed)
- ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU stay ≥ 48h
Key exclusion criteria (1 listed)
- Pregnant or nursing woman's job
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: 5 years after the first acute kidney injury requiring renal replacement therapy
incidence of chronic kidney disease in patients who had an acute kidney injury during their ICU stay and requiring an renal replacement therapy
5 secondary outcomes
severity of CKD according to the International Classification of Chronic Kidney Disease
Time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
impact of the renal replacement therapy on long-term renal function
Time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
quality of life
Time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
Activities of daily living
Time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
Mortality
Time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Derived from this study: PubMed 36447221Soum E, Timsit JF, Ruckly S, Gruson D, Canet E, Klouche K, Argaud L, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Darmon M, Bohe J, Schwebel C, Bouadma L, Dupuis C, Souweine B, Lautrette A. Predictive factors for severe long-term chronic kidney disease after acute kidney injury requiring renal replacement therapy in critically ill patients: an ancillary study of the ELVIS randomized controlled trial. Crit Care. 2022 Nov 29;26(1):367. doi: 10.1186/s13054-022-04233-4.
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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.
Alexandre LAUTRETTE principal investigator
University Hospital, Clermont-Ferrand
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 Injuries and Quality of Life, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of chronic kidney disease (time frame: 5 years after the first acute kidney injury requiring renal replacement therapy). 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 NCT03302624, which also lists 1 linked publication.
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 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.