Prediction of Sepsis After Percutaneous Nephrolithotomy

A Pre-operative Nomogram for Sepsis After Percutaneous Nephrolithotomy Treating Solitary, Unilateral, and Proximal Ureteral Stones

We aim to determine the preoperative predictors of sepsis after percutaneous nephrolithotomy (PCNL) in patients with unilateral, solitary and proximal ureteral stones.

Study Overview

• Status: Completed
• Conditions: Urolithiasis; Infection; Percutaneous Nephrolithotomy; Albumin Globulin Ratio
• Intervention / Treatment: Procedure: percutaneous nephrolithotomy

• Study Type: Observational
• Enrollment (Actual): 745

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 745 patients who underwent PCNL from January 2012 to December 2018 were enrolled when meeting eligibility criteria

Description

Inclusion Criteria:

• (1) PCNL was performed to treat unilateral, solitary, and proximal ureteral stones; and (2) age ≥18 years

Exclusion Criteria:

• anatomical renal abnormalities (horseshoe kidney, solitary kidney, transplant kidney and kidney duplication)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
proximal ureteral stone patient; Patients underwent percutaneous nephrolithotomy treating unilateral, solitary and proximal ureteral stones.	Procedure: percutaneous nephrolithotomy; percutaneous surgery using nephroscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sepsis	the concurrence of infection and a minimum of two of the following within 48 hours of surgery: (1) heart rate >90/minute, (2) body temperature >38°C, (3) leukocyte count <4,000 cells/μL or >12,000 cells/μL, and (4) respiratory rate >20/minute	within 48 hour after surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urolithiasis
• Other Study ID Numbers: 2019S1035v2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data is not suitable to be public

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No