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NCT Number: NCT05317273

Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention

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.

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Key information

Conditions

Urosepsis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urinary Tract Stone Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with urinary tract calculi requiring surgical procedure

Exclusion criteria

  • Incomplete data

Treatment and study plan

Primary outcomes

  1. Rate of urosepsis diagnosis

    Time frame: 7 days after surgery

    According to urine exam and SIRS criteria of sepsis

  2. Date of urosepsis diagnosis

    Time frame: 7 days after surgery

    date of diagnosis of urosepsis

  3. Mortality rate

    Time frame: 30 days after surgery

    Number of deceased patient after surgery

Secondary outcomes

  1. Length of stay

    Time frame: 7 days after surgery

    • hospital stay
    • intensive care unit stay

  2. Rate of intensive care unit admission

    Time frame: 7 days after surgery

    Number of patients required ICU admission

  3. Rate of blood transfusion

    Time frame: 7 days after surgery

    Amount of blood transfusion in unit during admission

  4. Rate of mechanical ventilation requirement

    Time frame: 7 days after surgery

    Number of patient required mechanical ventilation support

  5. Rate of re-operation

    Time frame: 7 days after surgery

    Number of patients require second procedure at the same admission

  6. Prevalence of acute kidney injury

    Time frame: 30 days after surgery

    According to KDIGO criteria

  7. Rate of renal replacement therapy requirement

    Time frame: 30 days after surgery

    Number of patients require renal replacement therapy

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Incidence and Risk Factors of Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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