Prediction of Sepsis After Flexible Ureteroscopy

Completed

• Conditions: Urolithiasis; Surgery--Complications; Sepsis
• Interventions: Procedure: flexible ureteroscopy

• Registration Number: NCT04157452
• Lead Sponsor: Tongji Hospital

Brief Summary

Sepsis is a lethal complication of flexible ureteroscopy. The aim of this study is to identify predictors of sepsis after flexible ureteroscopy in patients with solitary proximal ureteral stones.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-10-20
• Status Verified: 2019-11
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 759

Inclusion Criteria

• history of fURS to treat unilateral, solitary, and proximal ureteral stones
• age ≥18 years

Exclusion Criteria

• anatomical renal abnormalities such as transplant kidney, solitary kidney, horseshoe kidney, and kidney duplication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
proximal ureteral stone patient	flexible ureteroscopy	-

Primary Outcome Measures

Name	Time	Method
complication-sepsis	within 48 hour after surgery	sepsis is defined as the concurrence of infection and at least 2 of the following 4 criteria: (1) body temperature \>38°C, (2) heart rate \>90/minute, (3) respiratory rate \>20/minute, and (4) leukocyte count \<4,000 cells/μL or \>12,000 cells/μL

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China