Clinical trial NCT05317273: Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention
Official title: Incidence and Risk Factors of Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urosepsis
Urinary Tract Stone
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 865
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with urinary tract calculi requiring surgical procedure; percutaneous nephro-ureterolithotrypsy (PCNL), Retrograde intrarenal surgery (RIRS), Ureteroscopic lithotrypsy (URSL) and open lithotomy in tertiary-care university hospital.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

- Adult patients with urinary tract calculi requiring surgical procedure

Exclusion Criteria:

- Incomplete data

Primary outcomes:
measure: Rate of urosepsis diagnosis
timeFrame: 7 days after surgery
measure: Date of urosepsis diagnosis
timeFrame: 7 days after surgery
measure: Mortality rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Length of stay
timeFrame: 7 days after surgery
measure: Rate of intensive care unit admission
timeFrame: 7 days after surgery
measure: Rate of blood transfusion
timeFrame: 7 days after surgery
measure: Rate of mechanical ventilation requirement
timeFrame: 7 days after surgery
measure: Rate of re-operation
timeFrame: 7 days after surgery
measure: Prevalence of acute kidney injury
timeFrame: 30 days after surgery
measure: Rate of renal replacement therapy requirement
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND
name: Aphichat Suphathamwit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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