Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.

NCT04669886 | Recruiting

• 1 other identifier: 20200234
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile.

Conditions

Nephrolithiasis; Urosepsis

Keywords

endotoxin; fever; infectious complications; endourology; percutaneous nephrolithotomy

Outcome Measures

Primary Outcomes (2)

• Number of participants at each endotoxin activity level after surgery.

  The endotoxin activity level assessed from blood samples will be categorized as low (\<0.40), intermediate (0.40-0.59) or high (≥0.60) endotoxin activity level. Analysis will be done via Endotoxin Activity Assay (EAA).

  Day 1 (within 30 minutes postoperative)

• Corelation of endotoxin activity level with post-operative infectious complication

  infectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.

  up to 24 hours

Study Arms (1)

endotoxin study group

Patients scheduled for Percutaneous Nephrolithotomy (PCNL) as surgical treatment for their kidney stones will be evaluated for postoperative endotoxin levels as a risk marker for sepsis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for PCNL as surgical treatment for their kidney stones at Jackson and the University of Miami Hospitals.

You may qualify if:

• Adults that is able to consent (≥ 18 years of age)
• Scheduled to undergo PCNL at Uhealth tower and Jackson Memorial Hospitals
• not currently immunosuppressed \[White blood count (WBC) \>= 2, not on immunosuppressive medications\]

You may not qualify if:

• unable to consent and \< 18 years of age
• currently immunosuppressed (WBC \< 2, not on immunosuppressive medications)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis; Fever

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hemendra N Shah

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hemendra N Shah

CONTACT

3052433246; hns35@miami.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of clinical Urology

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: November 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)