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NCT Number: NCT04669886

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

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

Recruiting

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Key information

Conditions

Nephrolithiasis Body Temperature Changes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fever Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases Urosepsis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Hemendra N Shah, MD

CONTACT

[email protected]

305-243-3246

Hemendra N Shah, MD

PRINCIPAL_INVESTIGATOR

Robert Marcovich, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hemendra N Shah

CONTACT

[email protected]

3052433246

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2020
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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