NCT06299215

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 13, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2025

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

February 9, 2024

Last Update Submit

February 19, 2026

Conditions

Keywords

acute kidney injuryrenal remplacement therapyhemodialysisacute respiratory distresshemodynamic failure

Outcome Measures

Primary Outcomes (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.

    up to 30 days after admission to intensive care

Secondary Outcomes (12)

  • Death

    up to 30 days after admission to intensive care

  • Stage 3 Acute kidney injury (KDIGO classification)

    up to 30 days after admission to intensive care

  • failure to recover renal function

    up to 30 days after admission to intensive care .

  • the incidence of acute renal failure defined by KDIGO 1

    up to 30 days after admission to intensive care

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

    up to 30 days after admission to intensive care

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients meeting the eligibility criteria over the period 2015-2022 will be included in the study.

You may qualify if:

  • Patients over 18 years of age
  • Hospitalized in intensive care for management of acute obstructive pyelonephritis
  • Patients affiliated to a Social Security System

You may not qualify if:

  • Pregnancy
  • Opposition to data use
  • Persons under legal protection (curatorship, guardianship), legal safeguards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Saint Louis

Paris, 75010, France

Location

Related Publications (10)

  • 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.

    PMID: 29065405BACKGROUND
  • 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.

    PMID: 31039739BACKGROUND
  • 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.

    PMID: 22413829BACKGROUND
  • 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.

    PMID: 32671605BACKGROUND
  • 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.

    PMID: 33169555BACKGROUND
  • 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.

    PMID: 30174285BACKGROUND
  • 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.

    PMID: 24037335BACKGROUND
  • 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.

    PMID: 29439607BACKGROUND
  • 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.

    PMID: 36947175BACKGROUND
  • 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.

    PMID: 28255614BACKGROUND

MeSH Terms

Conditions

PyelonephritisAcute Kidney InjuryAcute Lung Injury

Condition Hierarchy (Ancestors)

Nephritis, InterstitialNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPyelitisMale Urogenital DiseasesRenal InsufficiencyLung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Maxime Dr COUTROT, MD

    Hopital saint Louis-APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2024

First Posted

March 7, 2024

Study Start

May 13, 2024

Primary Completion

November 18, 2025

Study Completion

November 18, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations