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

Recruiting

• Conditions: Urosepsis; Nephrolithiasis

• Registration Number: NCT04669886
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-17
• Status Verified: 2023-11
• Study Start: 2023-11-01
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Primary Completion: 2025-04-30
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corelation of endotoxin activity level with post-operative infectious complication	up to 24 hours	infectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.
Number of participants at each endotoxin activity level after surgery.	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).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States