Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT04669886

Conditions

Nephrolithiasis

Urosepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Study ID

NCT04669886

Start date

Nov 1, 2023

Status verified date

Aug, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of participants at each endotoxin activity level after surgery. [ Time Frame: Day 1 (within 30 minutes postoperative) ]
  • Corelation of endotoxin activity level with post-operative infectious complication [ Time Frame: up to 24 hours ]

Central Contacts and Locations

Central contacts

Hemendra N Shah

3052433246hns35@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Hemendra N Shah, MD

3052433246hns35@miami.edu

drhemendrashah@yahoo.co.in

Principal Investigator:

Hemendra N Shah, MD

More Information

Sponsor

University of Miami

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-27.