Factors and Prognosis of Obstructive Pyelonephritis Patients

Pyelonephritis Clinical Trial

— PYELO-OBS  

Official title:

Factors Associated With the Prognosis of Patients Admitted to for Acute Obstructive Pyelonephritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06299215
• Other study ID #: APHP240044
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Prognostic
• Pyelonephritis

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