Recruiting NCT04669886
Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.
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 →
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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