Renal Failure ChronicIR-EST-POSTCOVNCT05077163
Patients With Acute Renal Failure During Severe COVID-19
An observational study of Renal Failure Chronic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The occurrence of renal failure during severe forms of COVID-19 is common (20-35% of patients treated in intensive care) and associated with an unfavorable short-term prognosis, but the medium-term renal outcome is not is not known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to Dec 2021
- 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
- Adult, Older adult
Study population: - Major subject hospitalized in an intensive care unit, Strasbourg, Nancy or Reims Hospitals, for severe COVID-19 between February 1, 2020 and July 31, 2020.
Who may be able to join
- Major subject (≥18 years old)
- Subject hospitalized in an intensive care unit, Strasbourg, Nancy or Reims hospitals, for severe COVID-19 between February 1, 2020 and July 31, 2020.
- Having presented acute renal failure KDIGO 2 (assessed on a doubling of serum creatinine compared to the patient's reference values) or 3 (serum creatinine greater than 3 times the patient's reference, or anuria, or any recourse to extra-purification renal)
- Having left hospital alive after initial treatment for COVID-19
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Néphrologie et Transplantation - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Bruno MOULIN, MD, PhD, 33 3 69 55 05 11, Bruno.Moulin@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Renal Assessment of Patients With Acute Renal Failure During Severe COVID-19
The occurrence of renal failure during severe forms of COVID-19 is common (20-35% of patients treated in intensive care) and associated with an unfavorable short-term prognosis, but the medium-term renal outcome is not is not known.
The aim of the study is to establish the frequency of chronic kidney failure after AKI KDIGO 2 and 3 occurring during severe COVID-19 in intensive care.
- Conditions
- Renal Failure Chronic
- Keywords
- COVID-19, SARS-COV-2, Renal failure
- Medical subject headings
- Renal Insufficiency, Chronic, COVID-19, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of renal development in patients with acute renal failure during severe COVID-19
Measured: Files analysed retrospectively from February 01, 2020 to July 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Dec 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno MOULIN, MD, PhD, Principal investigator, Service de Néphrologie et Transplantation - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077163
- Sponsor's protocol ID
- 8039
- Acronym
- IR-EST-POSTCOV
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Assessment of Patients With Acute Renal Failure During Severe COVID-19
- ClinicalTrials.gov ID
- NCT05077163
- Acronym / sponsor ID
- IR-EST-POSTCOV / 8039
- Conditions
- Renal Failure Chronic
- Keywords
- COVID-19, SARS-COV-2, Renal failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Oct 2021 (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 occurrence of renal failure during severe forms of COVID-19 is common (20-35% of patients treated in intensive care) and associated with an unfavorable short-term prognosis, but the medium-term renal outcome is not is not known.
The aim of the study is to establish the frequency of chronic kidney failure after AKI KDIGO 2 and 3 occurring during severe COVID-19 in intensive care.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - Major subject hospitalized in an intensive care unit, Strasbourg, Nancy or Reims Hospitals, for severe COVID-19 between February 1, 2020 and July 31, 2020.
Key inclusion criteria (5 listed)
- Major subject (≥18 years old)
- Subject hospitalized in an intensive care unit, Strasbourg, Nancy or Reims hospitals, for severe COVID-19 between February 1, 2020 and July 31, 2020.
- Having presented acute renal failure KDIGO 2 (assessed on a doubling of serum creatinine compared to the patient's reference values) or 3 (serum creatinine greater than 3 times the patient's reference, or anuria, or any recourse to extra-purification renal)
- Having left hospital alive after initial treatment for COVID-19
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
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
Retrospective study of renal development in patients with acute renal failure during severe COVID-19
Time frame: Files analysed retrospectively from February 01, 2020 to July 31, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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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.
Saïd CHAYER, PhD, HDR contact
Bruno MOULIN, MD, PhD principal investigator
Service de Néphrologie et Transplantation - Hôpitaux Universitaires de Strasbourg
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 Renal Failure Chronic, run by University Hospital, Strasbourg, France 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 3 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 14 Oct 2021. 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 Bruno MOULIN, MD, PhD (33 3 69 55 05 11, Bruno.Moulin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of renal development in patients with acute renal failure during severe COVID-19 (time frame: Files analysed retrospectively from February 01, 2020 to July 31, 2020 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021.