NephrolithiasisNCT04669886
Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.
An observational study of Nephrolithiasis and Urosepsis, run by University of Miami at 1 site in United States.
Trial summary
The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Urosepsis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for PCNL as surgical treatment for their kidney stones at Jackson and the University of Miami Hospitals.
Who may be able to join
- 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]
Who cannot join
- unable to consent and < 18 years of age
- currently immunosuppressed (WBC < 2, not on immunosuppressive medications)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Hemendra N Shah, MD, 3052433246, hns35@miami.edu
drhemendrashah@yahoo.co.in
About this study
The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile.
- Conditions
- Nephrolithiasis, Urosepsis
- Keywords
- endotoxin, fever, infectious complications, endourology, percutaneous nephrolithotomy
- Medical subject headings
- Nephrolithiasis, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 (within 30 minutes postoperative)
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.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Nov 2023
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hemendra Shah, University of Miami
- Investigators
- Hemendra N Shah, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669886
- Sponsor's protocol ID
- 20200234
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2020
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.
- ClinicalTrials.gov ID
- NCT04669886
- Acronym / sponsor ID
- 20200234
- Conditions
- Nephrolithiasis, Urosepsis
- Keywords
- endotoxin, fever, infectious complications, endourology, percutaneous nephrolithotomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for PCNL as surgical treatment for their kidney stones at Jackson and the University of Miami Hospitals.
Key inclusion criteria (3 listed)
- 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]
Key exclusion criteria (2 listed)
- unable to consent and < 18 years of age
- currently immunosuppressed (WBC < 2, not on immunosuppressive medications)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants at each endotoxin activity level after surgery.
Time frame: 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 complication
Time frame: up to 24 hours
infectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hemendra N Shah principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrolithiasis and Urosepsis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hemendra N Shah (3052433246, hns35@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants at each endotoxin activity level after surgery. (time frame: Day 1 (within 30 minutes postoperative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.