Prediction of Sepsis After Percutaneous Nephrolithotomy

NCT04340037 | Completed

• 1 other identifier: 2019S1035v2
• Study Type: observational
• Target: 745
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Percutaneous Nephrolithotomy; Infection; Urolithiasis; Albumin Globulin Ratio

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

proximal ureteral stone patient

Patients underwent percutaneous nephrolithotomy treating unilateral, solitary and proximal ureteral stones.

Procedure: percutaneous nephrolithotomy

Interventions

percutaneous nephrolithotomy PROCEDURE

percutaneous surgery using nephroscope

proximal ureteral stone patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Infections; Urolithiasis

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 9, 2020
• Study Start: March 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 20, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)