Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05317273
Collaborator
(none)
865
1
21
41.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    865 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Incidence and Risk Factors of Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention
    Actual Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Apr 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Rate of urosepsis diagnosis [7 days after surgery]

      According to urine exam and SIRS criteria of sepsis

    2. Date of urosepsis diagnosis [7 days after surgery]

      date of diagnosis of urosepsis

    3. Mortality rate [30 days after surgery]

      Number of deceased patient after surgery

    Secondary Outcome Measures

    1. Length of stay [7 days after surgery]

      hospital stay intensive care unit stay

    2. Rate of intensive care unit admission [7 days after surgery]

      Number of patients required ICU admission

    3. Rate of blood transfusion [7 days after surgery]

      Amount of blood transfusion in unit during admission

    4. Rate of mechanical ventilation requirement [7 days after surgery]

      Number of patient required mechanical ventilation support

    5. Rate of re-operation [7 days after surgery]

      Number of patients require second procedure at the same admission

    6. Prevalence of acute kidney injury [30 days after surgery]

      According to KDIGO criteria

    7. Rate of renal replacement therapy requirement [30 days after surgery]

      Number of patients require renal replacement therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients with urinary tract calculi requiring surgical procedure
    Exclusion Criteria:
    • Incomplete data

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok Noi Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Aphichat Suphathamwit, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Aphichat Suphathamwit,, Assistant Professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT05317273
    Other Study ID Numbers:
    • 2022_1
    First Posted:
    Apr 7, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022