Back to search results

Observational Study on Endotoxin Levels and Post-Surgery Infections

This study is looking at how levels of endotoxin (a substance released by certain bacteria) in your blood before and after surgery might predict your risk of getting an infection or a strong inflammatory reaction after a procedure called percutaneous nephrolithotomy (PCNL). PCNL is a surgery to remove kidney stones (nephrolithiasis). Researchers will measure your endotoxin levels after surgery and see if these levels are linked to whether you develop an infection. You may be able to join if you are an adult (18 or older), are scheduled for PCNL at Uhealth Tower or Jackson Memorial Hospitals, and are not currently taking medicines that weaken your immune system. The study aims to create a system to predict infection risk based on these blood tests. The current recruitment status is unclear.

Study design
This is an observational study involving 150 participants. It aims to understand the relationship between endotoxin levels and post-operative complications.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your endotoxin activity level will be measured within 30 minutes after surgery, and researchers will look for any correlation with post-operative infectious complications for up to 24 hours.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04669886

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

Recruiting
Not specifiedAges 18+Observational
University of Miami
~150 participants
Updated 2026-08-27 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants at each endotoxin activity level after surgery.
Measured over Day 1 (within 30 minutes postoperative)
+1 more outcome measured

Conditions

Nephrolithiasis
Urosepsis

Explore related trials

Nephrolithiasis

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Hemendra N Shah · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Hemendra N Shah
[email protected]
3052433246
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

unable to consent and \< 18 years of age
currently immunosuppressed (WBC \< 2, not on immunosuppressive medications)

What this trial measures

  • 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 hours

    infectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.