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

NCT ID: NCT04669886

Last Updated: 2025-09-03

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

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-12-01

Brief Summary

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

Detailed Description

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Conditions

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Nephrolithiasis Urosepsis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Hemendra Shah

Associate Professor of clinical Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hemendra N Shah

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hemendra N Shah

Role: CONTACT

3052433246

Facility Contacts

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Hemendra N Shah, MD

Role: primary

305-243-3246

Role: backup

Other Identifiers

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20200234

Identifier Type: -

Identifier Source: org_study_id

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