Clinical trial NCT06299215: Factors and Prognosis of Obstructive Pyelonephritis Patients
Official title: Factors Associated With the Prognosis of Patients Admitted to for Acute Obstructive Pyelonephritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pyelonephritis
Prognostic
Keywords: acute kidney injury
renal remplacement therapy
hemodialysis
acute respiratory distress
hemodynamic failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting the eligibility criteria over the period 2015-2022 will be included in the study.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
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.
timeFrame: up to 30 days after admission to intensive care
Secondary outcomes:
measure: Death
timeFrame: up to 30 days after admission to intensive care
measure: Stage 3 Acute kidney injury (KDIGO classification)
timeFrame: up to 30 days after admission to intensive care
measure: failure to recover renal function
timeFrame: up to 30 days after admission to intensive care .
measure: the incidence of acute renal failure defined by KDIGO 1
timeFrame: up to 30 days after admission to intensive care
measure: the incidence of acute renal failure defined by KDIGO 2 and 3
timeFrame: up to 30 days after admission to intensive care
measure: the incidence of Renal replacement therapy
timeFrame: up to 30 days after admission to intensive care
measure: the incidence of non-recovery of renal fuction
timeFrame: up to 30 days after admission to intensive care
measure: The number of days alive without Renal replacement therapy
timeFrame: up to 30 days after admission to intensive care
measure: The number of days alive without catecholamines
timeFrame: up to 30 days after admission to intensive care
measure: The number of days alive without antibiotics
timeFrame: up to 30 days after admission to intensive care
measure: The number of days alive without
timeFrame: up to 30 days after admission to intensive care
measure: Death rate
timeFrame: up to 30 days after admission to intensive care
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Saint Louis
Study officials:
affiliation: Hopital saint Louis-APHP
name: Maxime Dr COUTROT, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.