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

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04669886
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 19.1
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nephrolithiasis; Urosepsis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.
• Anticipated Study Start Date: Aug 30, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Number of participants at each endotoxin activity level after surgery. [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 [up to 24 hours]

   infectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Hemendra N Shah, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hemendra Shah, Associate Professor of clinical Urology, University of Miami
• ClinicalTrials.gov Identifier: NCT04669886
• Other Study ID Numbers: 20200234
• First Posted: Dec 17, 2020
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hemendra Shah, Associate Professor of clinical Urology, University of Miami: endotoxin; fever; infectious complications; endourology; percutaneous nephrolithotomy
• Additional relevant MeSH terms: Communicable Diseases; Infections; Nephrolithiasis; Kidney Calculi

Study Results

No Results Posted as of Jul 12, 2022