Pyelonephritis Clinical Trial
— PYELO-OBSOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hospital Saint Louis | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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
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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