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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT04669886
Status
Recruiting
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Conditions

  • Nephrolithiasis
  • Urosepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

Start date
Nov 1, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Number of participants at each endotoxin activity level after surgery. [ Time Frame: Day 1 (within 30 minutes postoperative) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Hemendra N Shah, MD
[email protected]
305-243-3246
[email protected]
Hemendra N Shah, MD (PRINCIPAL_INVESTIGATOR)
Robert Marcovich, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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