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

University of Miami150 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Nephrolithiasis Urosepsis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: up to 24 hours

Central Contacts

Hemendra N Shah

CONTACT

3052433246 hns35@miami.edu

Data from ClinicalTrials.gov

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