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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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]

Disqualifiers

unable to consent and < 18 years of age

currently immunosuppressed (WBC < 2, not on immunosuppressive medications)

Trial population

Patients scheduled for PCNL as surgical treatment for their kidney stones at Jackson and the University of Miami Hospitals.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: endotoxin study group

Trial outcomes

Primary outcomes

1

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)
2

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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