Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention

Completed

• Conditions: Urosepsis; Urinary Tract Stone

• Registration Number: NCT05317273
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2022-08-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 865

Inclusion Criteria

• Adult patients with urinary tract calculi requiring surgical procedure

Exclusion Criteria

• Incomplete data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of urosepsis diagnosis	7 days after surgery	According to urine exam and SIRS criteria of sepsis
Date of urosepsis diagnosis	7 days after surgery	date of diagnosis of urosepsis
Mortality rate	30 days after surgery	Number of deceased patient after surgery

Secondary Outcome Measures

Name	Time	Method
Rate of intensive care unit admission	7 days after surgery	Number of patients required ICU admission
Length of stay	7 days after surgery	* hospital stay; * intensive care unit stay
Rate of mechanical ventilation requirement	7 days after surgery	Number of patient required mechanical ventilation support
Rate of renal replacement therapy requirement	30 days after surgery	Number of patients require renal replacement therapy
Prevalence of acute kidney injury	30 days after surgery	According to KDIGO criteria
Rate of blood transfusion	7 days after surgery	Amount of blood transfusion in unit during admission
Rate of re-operation	7 days after surgery	Number of patients require second procedure at the same admission

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand