AzTrials
AzTrials

UrosepsisNCT05317273

Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention

An observational study of Urosepsis and Urinary Tract Stone, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urosepsis, Urinary Tract Stone
How many people
865 participants
Where
1 siteThailand
Study dates
1 Aug 2022to 30 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Adult patients with urinary tract calculi requiring surgical procedure

Who cannot join

  • Incomplete data

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: Incidence and Risk Factors of 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.

Read the 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.

Medical subject headings
Urinary Calculi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of urosepsis diagnosis

    According to urine exam and SIRS criteria of sepsis

    Measured: 7 days after surgery

  2. Date of urosepsis diagnosis

    date of diagnosis of urosepsis

    Measured: 7 days after surgery

  3. Mortality rate

    Number of deceased patient after surgery

    Measured: 30 days after surgery

Secondary outcomes (7)

  1. Length of stay

    • hospital stay
    • intensive care unit stay

    Measured: 7 days after surgery

  2. Rate of intensive care unit admission

    Number of patients required ICU admission

    Measured: 7 days after surgery

  3. Rate of blood transfusion

    Amount of blood transfusion in unit during admission

    Measured: 7 days after surgery

  4. Rate of mechanical ventilation requirement

    Number of patient required mechanical ventilation support

    Measured: 7 days after surgery

  5. Rate of re-operation

    Number of patients require second procedure at the same admission

    Measured: 7 days after surgery

  6. Prevalence of acute kidney injury

    According to KDIGO criteria

    Measured: 30 days after surgery

  7. Rate of renal replacement therapy requirement

    Number of patients require renal replacement therapy

    Measured: 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Mar 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
865 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05317273
Sponsor's protocol ID
2022_1
Status last verified
Nov 2024
First submitted
20 Mar 2022
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30569755

  • 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.

    PubMed 27317017

  • 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.

    PubMed 34569289

  • 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.

    PubMed 33887891

  • 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.

    PubMed 26903338

  • 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.

    PubMed 27649072

  • 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.

    PubMed 15273542

Questions about this trial

What is this clinical trial studying?

An observational study of Urosepsis and Urinary Tract Stone, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of urosepsis diagnosis (time frame: 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05317273, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in