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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04669886
Enrollment
150
Registered
2020-12-17
Start date
2023-11-01
Completion date
2027-12-30
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrolithiasis, Urosepsis

Keywords

endotoxin, fever, infectious complications, endourology, percutaneous nephrolithotomy

Brief summary

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

Interventions

None listed

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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).
Corelation of endotoxin activity level with post-operative infectious complicationup to 24 hoursinfectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.

Countries

United States

Contacts

CONTACTHemendra N Shah
hns35@miami.edu3052433246
PRINCIPAL_INVESTIGATORHemendra N Shah

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026