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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site

  • Hospital Saint Louis

    Paris, 75010

Other trials in France

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.

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.

  1. 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)

  1. Death

    Measured: up to 30 days after admission to intensive care

  2. Stage 3 Acute kidney injury (KDIGO classification)

    Measured: up to 30 days after admission to intensive care

  3. 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 .

  4. the incidence of acute renal failure defined by KDIGO 1

    Measured: up to 30 days after admission to intensive care

  5. the incidence of acute renal failure defined by KDIGO 2 and 3

    Measured: up to 30 days after admission to intensive care

  6. the incidence of Renal replacement therapy

    Measured: up to 30 days after admission to intensive care

  7. the incidence of non-recovery of renal fuction

    Measured: up to 30 days after admission to intensive care

  8. The number of days alive without Renal replacement therapy

    Measured: up to 30 days after admission to intensive care

  9. The number of days alive without catecholamines

    Measured: up to 30 days after admission to intensive care

  10. The number of days alive without antibiotics

    Measured: up to 30 days after admission to intensive care

  11. The number of days alive without

    Measured: up to 30 days after admission to intensive care

  12. 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.

  1. First posted7 Mar 2024
  2. Study start13 May 2024
  3. Primary completion18 Nov 2025
  4. Study completion18 Nov 2025

Resources

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)
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 29065405

  • Liang 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 31039739

  • Yamamoto 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 22413829

  • Baboudjian 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 32671605

  • Lee 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 33169555

  • Yamamichi 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 30174285

  • Tambo 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 24037335

  • Srougi 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 29439607

  • Kamei 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 36947175

  • Kellum 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

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.

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