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Recruiting NCT04669886

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

Observational Nephrolithiasis Urosepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Nephrolithiasis, Urosepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT04669886 · 20200234

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗