PyelonephritisPYELO-OBSNCT06299215
Factors and Prognosis of Obstructive Pyelonephritis Patients
An observational study of Pyelonephritis and Prognostic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit. Most of the available data on this condition comes from small, retrospective, single-centre series. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pyelonephritis, Prognostic
- How many people
- 575 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2024to 18 Nov 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients meeting the eligibility criteria over the period 2015-2022 will be included in the study.
Who may be able to join
- Patients over 18 years of age
- Hospitalized in intensive care for management of acute obstructive pyelonephritis
- Patients affiliated to a Social Security System
Who cannot join
- Pregnancy
- Opposition to data use
- Persons under legal protection (curatorship, guardianship), legal safeguards
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With the Prognosis of Patients Admitted to for Acute Obstructive Pyelonephritis
Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.
Most of the available data on this condition comes from small, retrospective, single-centre series.
To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.
The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients.
Read the detailed description
The retrospective and multicenter study consists of a retrospective and pseudonymous collection of data from medical reports of patients treated, over the period 2015-2022, in each intensive care unit agreeing to participate, .
Investigators from each participating center will be responsible for screening on all hospitalized patients over the period 2015-2022. Patients who have been hospitalized for the management of acute obstructive pyelonephritis will be included, in the absence of non-inclusion criteria.
- Conditions
- Pyelonephritis, Prognostic
- Keywords
- acute kidney injury, renal remplacement therapy, hemodialysis, acute respiratory distress, hemodynamic failure
- Medical subject headings
- Pyelonephritis, Acute Kidney Injury, Acute Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function.
Measured: up to 30 days after admission to intensive care
Secondary outcomes (12)
Death
Measured: up to 30 days after admission to intensive care
Stage 3 Acute kidney injury (KDIGO classification)
Measured: up to 30 days after admission to intensive care
failure to recover renal function
defined as creatinine levels greater than 150% of baseline value
Measured: up to 30 days after admission to intensive care .
the incidence of acute renal failure defined by KDIGO 1
Measured: up to 30 days after admission to intensive care
the incidence of acute renal failure defined by KDIGO 2 and 3
Measured: up to 30 days after admission to intensive care
the incidence of Renal replacement therapy
Measured: up to 30 days after admission to intensive care
the incidence of non-recovery of renal fuction
Measured: up to 30 days after admission to intensive care
The number of days alive without Renal replacement therapy
Measured: up to 30 days after admission to intensive care
The number of days alive without catecholamines
Measured: up to 30 days after admission to intensive care
The number of days alive without antibiotics
Measured: up to 30 days after admission to intensive care
The number of days alive without
Measured: up to 30 days after admission to intensive care
Death rate
Measured: up to 30 days after admission to intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start13 May 2024
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PyelonephritisStudies 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
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Dr COUTROT, MD, Principal investigator, Hopital saint Louis-APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299215
- Sponsor's protocol ID
- APHP240044
- Acronym
- PYELO-OBS
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kakinoki H, Tobu S, Kakinoki Y, Udo K, Uozumi J, Noguchi M. Risk Factors for Uroseptic Shock in Patients with Urolithiasis-Related Acute Pyelonephritis. Urol Int. 2018;100(1):37-42. doi: 10.1159/000481801. Epub 2017 Oct 24.
PubMed 29065405Liang X, Huang J, Xing M, He L, Zhu X, Weng Y, Guo Q, Zou W. Risk factors and outcomes of urosepsis in patients with calculous pyonephrosis receiving surgical intervention: a single-center retrospective study. BMC Anesthesiol. 2019 May 1;19(1):61. doi: 10.1186/s12871-019-0729-3.
PubMed 31039739Yamamoto Y, Fujita K, Nakazawa S, Hayashi T, Tanigawa G, Imamura R, Hosomi M, Wada D, Fujimi S, Yamaguchi S. Clinical characteristics and risk factors for septic shock in patients receiving emergency drainage for acute pyelonephritis with upper urinary tract calculi. BMC Urol. 2012 Mar 13;12:4. doi: 10.1186/1471-2490-12-4.
PubMed 22413829Baboudjian M, Gondran-Tellier B, Di Bisceglie M, Abdallah R, Michel F, Sichez PC, Al-Balushi K, Akiki A, Gaillet S, Delaporte V, Karsenty G, Lechevallier E, Guieu R, Boissier R. The prognostic value of serum procalcitonin in acute obstructive pyelonephritis. World J Urol. 2021 May;39(5):1583-1589. doi: 10.1007/s00345-020-03353-2. Epub 2020 Jul 15.
PubMed 32671605Lee SH, Choi T, Choi J, Yoo KH. Differences between Risk Factors for Sepsis and Septic Shock in Obstructive Urolithiasis. J Korean Med Sci. 2020 Nov 9;35(43):e359. doi: 10.3346/jkms.2020.35.e359.
PubMed 33169555Yamamichi F, Shigemura K, Kitagawa K, Fujisawa M. Comparison between non-septic and septic cases in stone-related obstructive acute pyelonephritis and risk factors for septic shock: A multi-center retrospective study. J Infect Chemother. 2018 Nov;24(11):902-906. doi: 10.1016/j.jiac.2018.08.002. Epub 2018 Aug 30.
PubMed 30174285Tambo M, Okegawa T, Shishido T, Higashihara E, Nutahara K. Predictors of septic shock in obstructive acute pyelonephritis. World J Urol. 2014 Jun;32(3):803-11. doi: 10.1007/s00345-013-1166-4. Epub 2013 Sep 15.
PubMed 24037335Srougi V, Moscardi PR, Marchini GS, Berjeaut RH, Torricelli FC, Mesquita JLB, Srougi M, Mazzucchi E. Septic Shock Following Surgical Decompression of Obstructing Ureteral Stones: A Prospective Analysis. J Endourol. 2018 May;32(5):446-450. doi: 10.1089/end.2017.0896. Epub 2018 Mar 20.
PubMed 29439607Kamei J, Sugihara T, Yasunaga H, Matsui H, Sasabuchi Y, Fujimura T, Homma Y, Kume H. Impact of early ureteral drainage on mortality in obstructive pyelonephritis with urolithiasis: an analysis of the Japanese National Database. World J Urol. 2023 May;41(5):1365-1371. doi: 10.1007/s00345-023-04375-2. Epub 2023 Mar 22.
PubMed 36947175Kellum JA, Zarbock A, Nadim MK. What endpoints should be used for clinical studies in acute kidney injury? Intensive Care Med. 2017 Jun;43(6):901-903. doi: 10.1007/s00134-017-4732-1. Epub 2017 Mar 2. No abstract available.
PubMed 28255614
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With the Prognosis of Patients Admitted to for Acute Obstructive Pyelonephritis
- ClinicalTrials.gov ID
- NCT06299215
- Acronym / sponsor ID
- PYELO-OBS / APHP240044
- Conditions
- Pyelonephritis, Prognostic
- Keywords
- acute kidney injury, renal remplacement therapy, hemodialysis, acute respiratory distress, hemodynamic failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 7 Mar 2024 (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 obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.
Most of the available data on this condition comes from small, retrospective, single-centre series.
To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.
The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients.
Detailed description
The retrospective and multicenter study consists of a retrospective and pseudonymous collection of data from medical reports of patients treated, over the period 2015-2022, in each intensive care unit agreeing to participate, .
Investigators from each participating center will be responsible for screening on all hospitalized patients over the period 2015-2022. Patients who have been hospitalized for the management of acute obstructive pyelonephritis will be included, in the absence of non-inclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting the eligibility criteria over the period 2015-2022 will be included in the study.
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Hospitalized in intensive care for management of acute obstructive pyelonephritis
- Patients affiliated to a Social Security System
Key exclusion criteria (3 listed)
- Pregnancy
- Opposition to data use
- Persons under legal protection (curatorship, guardianship), legal safeguards
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
The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function.
Time frame: up to 30 days after admission to intensive care
12 secondary outcomes
Death
Time frame: up to 30 days after admission to intensive care
Stage 3 Acute kidney injury (KDIGO classification)
Time frame: up to 30 days after admission to intensive care
failure to recover renal function
Time frame: up to 30 days after admission to intensive care .
the incidence of acute renal failure defined by KDIGO 1
Time frame: up to 30 days after admission to intensive care
the incidence of acute renal failure defined by KDIGO 2 and 3
Time frame: up to 30 days after admission to intensive care
the incidence of Renal replacement therapy
Time frame: up to 30 days after admission to intensive care
the incidence of non-recovery of renal fuction
Time frame: up to 30 days after admission to intensive care
The number of days alive without Renal replacement therapy
Time frame: up to 30 days after admission to intensive care
The number of days alive without catecholamines
Time frame: up to 30 days after admission to intensive care
The number of days alive without antibiotics
Time frame: up to 30 days after admission to intensive care
The number of days alive without
Time frame: up to 30 days after admission to intensive care
Death rate
Time frame: up to 30 days after admission to intensive care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 29065405Kakinoki H, Tobu S, Kakinoki Y, Udo K, Uozumi J, Noguchi M. Risk Factors for Uroseptic Shock in Patients with Urolithiasis-Related Acute Pyelonephritis. Urol Int. 2018;100(1):37-42. doi: 10.1159/000481801. Epub 2017 Oct 24.
- Background: PubMed 31039739Liang X, Huang J, Xing M, He L, Zhu X, Weng Y, Guo Q, Zou W. Risk factors and outcomes of urosepsis in patients with calculous pyonephrosis receiving surgical intervention: a single-center retrospective study. BMC Anesthesiol. 2019 May 1;19(1):61. doi: 10.1186/s12871-019-0729-3.
- Background: PubMed 22413829Yamamoto Y, Fujita K, Nakazawa S, Hayashi T, Tanigawa G, Imamura R, Hosomi M, Wada D, Fujimi S, Yamaguchi S. Clinical characteristics and risk factors for septic shock in patients receiving emergency drainage for acute pyelonephritis with upper urinary tract calculi. BMC Urol. 2012 Mar 13;12:4. doi: 10.1186/1471-2490-12-4.
- Background: PubMed 32671605Baboudjian M, Gondran-Tellier B, Di Bisceglie M, Abdallah R, Michel F, Sichez PC, Al-Balushi K, Akiki A, Gaillet S, Delaporte V, Karsenty G, Lechevallier E, Guieu R, Boissier R. The prognostic value of serum procalcitonin in acute obstructive pyelonephritis. World J Urol. 2021 May;39(5):1583-1589. doi: 10.1007/s00345-020-03353-2. Epub 2020 Jul 15.
- Background: PubMed 33169555Lee SH, Choi T, Choi J, Yoo KH. Differences between Risk Factors for Sepsis and Septic Shock in Obstructive Urolithiasis. J Korean Med Sci. 2020 Nov 9;35(43):e359. doi: 10.3346/jkms.2020.35.e359.
- Background: PubMed 30174285Yamamichi F, Shigemura K, Kitagawa K, Fujisawa M. Comparison between non-septic and septic cases in stone-related obstructive acute pyelonephritis and risk factors for septic shock: A multi-center retrospective study. J Infect Chemother. 2018 Nov;24(11):902-906. doi: 10.1016/j.jiac.2018.08.002. Epub 2018 Aug 30.
- Background: PubMed 24037335Tambo M, Okegawa T, Shishido T, Higashihara E, Nutahara K. Predictors of septic shock in obstructive acute pyelonephritis. World J Urol. 2014 Jun;32(3):803-11. doi: 10.1007/s00345-013-1166-4. Epub 2013 Sep 15.
- Background: PubMed 29439607Srougi V, Moscardi PR, Marchini GS, Berjeaut RH, Torricelli FC, Mesquita JLB, Srougi M, Mazzucchi E. Septic Shock Following Surgical Decompression of Obstructing Ureteral Stones: A Prospective Analysis. J Endourol. 2018 May;32(5):446-450. doi: 10.1089/end.2017.0896. Epub 2018 Mar 20.
- Background: PubMed 36947175Kamei J, Sugihara T, Yasunaga H, Matsui H, Sasabuchi Y, Fujimura T, Homma Y, Kume H. Impact of early ureteral drainage on mortality in obstructive pyelonephritis with urolithiasis: an analysis of the Japanese National Database. World J Urol. 2023 May;41(5):1365-1371. doi: 10.1007/s00345-023-04375-2. Epub 2023 Mar 22.
- Background: PubMed 28255614Kellum JA, Zarbock A, Nadim MK. What endpoints should be used for clinical studies in acute kidney injury? Intensive Care Med. 2017 Jun;43(6):901-903. doi: 10.1007/s00134-017-4732-1. Epub 2017 Mar 2. No abstract available.
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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.
Maxime Dr COUTROT, MD principal investigator
Hopital saint Louis-APHP
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 Pyelonephritis and Prognostic, 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 3 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: finished, as of the sponsor's last update on 20 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function. (time frame: up to 30 days after admission to intensive care). 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 NCT06299215, which also lists 10 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 20 Feb 2026.