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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06299215
Other study ID # APHP240044
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2024
Est. completion date March 1, 2026

Study information

Verified date March 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Maxime Dr COUTROT, MD
Phone 01 42 49 93 94
Email maxime.coutrot@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date March 1, 2026
Est. primary completion date March 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hospital Saint Louis Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Death up to 30 days after admission to intensive care
Secondary Stage 3 Acute kidney injury (KDIGO classification) up to 30 days after admission to intensive care
Secondary failure to recover renal function defined as creatinine levels greater than 150% of baseline value up to 30 days after admission to intensive care .
Secondary the incidence of acute renal failure defined by KDIGO 1 up to 30 days after admission to intensive care
Secondary the incidence of acute renal failure defined by KDIGO 2 and 3 up to 30 days after admission to intensive care
Secondary the incidence of Renal replacement therapy up to 30 days after admission to intensive care
Secondary the incidence of non-recovery of renal fuction up to 30 days after admission to intensive care
Secondary The number of days alive without Renal replacement therapy up to 30 days after admission to intensive care
Secondary The number of days alive without catecholamines up to 30 days after admission to intensive care
Secondary The number of days alive without antibiotics up to 30 days after admission to intensive care
Secondary The number of days alive without up to 30 days after admission to intensive care
Secondary Death rate up to 30 days after admission to intensive care
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