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

September 1, 2025 updated by: Hemendra Shah, University of Miami
The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hemendra N Shah, MD
        • Principal Investigator:
          • Robert Marcovich, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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]

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants at each endotoxin activity level after surgery.
Time Frame: Day 1 (within 30 minutes postoperative)
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
Time Frame: up to 24 hours
infectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Hemendra N Shah, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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