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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05317273
Other study ID # 2022_1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date April 30, 2024

Study information

Verified date January 2024
Source Mahidol University
Contact Aphichat Suphathamwit, M.D.
Phone 0982786069
Email aphichat.suh@mahidol.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Urosepsis is one of major cause of the overall sepsis leading to high morbidity and mortality, which commonly resulted from urinary tract calculi. The investigator aim to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital.


Description:

Sepsis is one of the leading cause of death of hospitalized patients in Thailand. Urosepsis or sepsis which originate from urinary tract infection was reported around 9-31% of the overall sepsis syndrome. Urinary tract calculi requiring surgical procedure was reported as a common cause of urinary tract infection. Therefore, the investigators aimed to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital. Moreover, the patients with sepsis syndrome will be suffered from many complications such as acute respiratory distress syndrome, acute kidney injury, etc. Currently, there were many early waring scores to predict the risk of complications to help promptly treatment and decrease the severity. The investigator would like to compare the systemic inflammatory response syndrome (SIRS) criteria,Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) score to the prediction of postoperative complications in this group of patients. The last primary objective of this study is to follow the course of the patients diagnosed as urosepsis if they had been treated properly according to the sepsis bundle guideline and their outcome.


Recruitment information / eligibility

Status Recruiting
Enrollment 865
Est. completion date April 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with urinary tract calculi requiring surgical procedure Exclusion Criteria: - Incomplete data

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok Noi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

Amier Y, Zhang Y, Zhang J, Yao W, Wang S, Wei C, Yu X. Analysis of Preoperative Risk Factors for Postoperative Urosepsis After Mini-Percutaneous Nephrolithotomy in Patients with Large Kidney Stones. J Endourol. 2022 Mar;36(3):292-297. doi: 10.1089/end.2021.0406. — View Citation

Blackmur JP, Maitra NU, Marri RR, Housami F, Malki M, McIlhenny C. Analysis of Factors' Association with Risk of Postoperative Urosepsis in Patients Undergoing Ureteroscopy for Treatment of Stone Disease. J Endourol. 2016 Sep;30(9):963-9. doi: 10.1089/end.2016.0300. Epub 2016 Jul 13. — View Citation

Churpek MM, Snyder A, Han X, Sokol S, Pettit N, Howell MD, Edelson DP. Quick Sepsis-related Organ Failure Assessment, Systemic Inflammatory Response Syndrome, and Early Warning Scores for Detecting Clinical Deterioration in Infected Patients outside the Intensive Care Unit. Am J Respir Crit Care Med. 2017 Apr 1;195(7):906-911. doi: 10.1164/rccm.201604-0854OC. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. — View Citation

Grosso AA, Sessa F, Campi R, Viola L, Polverino P, Crisci A, Salvi M, Liatsikos E, Feu OA, DI Maida F, Tellini R, Traxer O, Cocci A, Mari A, Fiori C, Porpiglia F, Carini M, Tuccio A, Minervini A. Intraoperative and postoperative surgical complications after ureteroscopy, retrograde intrarenal surgery, and percutaneous nephrolithotomy: a systematic review. Minerva Urol Nephrol. 2021 Jun;73(3):309-332. doi: 10.23736/S2724-6051.21.04294-4. Epub 2021 Apr 22. — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Southern JB, Higgins AM, Young AJ, Kost KA, Schreiter BR, Clifton M, Fulmer BR, Garg T. Risk Factors for Postoperative Fever and Systemic Inflammatory Response Syndrome After Ureteroscopy for Stone Disease. J Endourol. 2019 Jul;33(7):516-522. doi: 10.1089/end.2018.0789. Epub 2019 Jan 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of urosepsis diagnosis According to urine exam and SIRS criteria of sepsis 7 days after surgery
Primary Date of urosepsis diagnosis date of diagnosis of urosepsis 7 days after surgery
Primary Mortality rate Number of deceased patient after surgery 30 days after surgery
Secondary Length of stay hospital stay
intensive care unit stay
7 days after surgery
Secondary Rate of intensive care unit admission Number of patients required ICU admission 7 days after surgery
Secondary Rate of blood transfusion Amount of blood transfusion in unit during admission 7 days after surgery
Secondary Rate of mechanical ventilation requirement Number of patient required mechanical ventilation support 7 days after surgery
Secondary Rate of re-operation Number of patients require second procedure at the same admission 7 days after surgery
Secondary Prevalence of acute kidney injury According to KDIGO criteria 30 days after surgery
Secondary Rate of renal replacement therapy requirement Number of patients require renal replacement therapy 30 days after surgery
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