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Simple blood test may predict infection after kidney stone surgery

NCT ID NCT04669886

Knowledge-focused Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study is testing whether a blood test that measures endotoxin levels can predict the risk of infection after a type of kidney stone surgery called percutaneous nephrolithotomy (PCNL). Researchers will enroll 150 adults scheduled for this surgery and measure their endotoxin levels before and after the procedure. The goal is to see if higher levels are linked to complications like fever or systemic inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test that helps doctors identify patients at high risk for infection after kidney stone surgery, allowing for earlier treatment.
What could go wrong
This is an early observational study, not a treatment trial. The blood test may not accurately predict infections, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Fever nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nephrolithiasis Urosepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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