ClinicalTrials.gg
RecruitingNCT04669886Updated Aug 27, 2026

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

An observational study in Nephrolithiasis and Urosepsis, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by University of Miami · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Nephrolithiasis
  • Urosepsis

Keywords

  • endotoxin
  • fever
  • infectious complications
  • endourology
  • percutaneous nephrolithotomy
03

In context

Nephrolithiasis

324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 57 observational studies indexed under Nephrolithiasis.

Browse Nephrolithiasis studies →

Lead sponsor

University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 [White blood count (WBC) >= 2, not on immunosuppressive medications]

Exclusion criteria

Exclusion Criteria:

  • unable to consent and \< 18 years of age
  • currently (WBC \< 2, not on immunosuppressive medications)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • endotoxin study group

    Patients scheduled for Percutaneous Nephrolithotomy (PCNL) as surgical treatment for their kidney stones will be evaluated for postoperative endotoxin levels as a risk marker for sepsis.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04669886
Responsible party
Hemendra Shah (Associate Professor of clinical Urology, University of Miami) — Principal investigator
First posted
Dec 17, 2020
Start date
Nov 1, 2023
Primary completion
Mar 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Hemendra N Shah
Contact
hns35@miami.edu
3052433246
Hemendra N Shah
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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