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NCT04669886 Clinical Trial

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

Nephrolithiasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04669886
Other study ID # 20200234
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date September 1, 2025

Study information
Verified date November 2023
Source University of Miami
Contact Hemendra N Shah
Phone 3052433246
Email hns35@miami.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date September 1, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). Day 1 (within 30 minutes postoperative)
Primary 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. up to 24 hours
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