Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention

NCT ID: NCT05317273

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

865 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urosepsis Urinary Tract Stone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Adult patients with urinary tract calculi requiring surgical procedure

Exclusion Criteria

\- Incomplete data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aphichat Suphathamwit,

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aphichat Suphathamwit, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30569755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27317017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34569289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33887891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26903338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27649072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15273542 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022_1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ultrasound Imaging of Kidney Stones and Lithotripsy
NCT02214836 ACTIVE_NOT_RECRUITING NA