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NCT04340037 Clinical Trial

Prediction of Sepsis After Percutaneous Nephrolithotomy

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04340037
Other study ID # 2019S1035v2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date February 20, 2020

Study information
Verified date April 2020
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 745
Est. completion date February 20, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• percutaneous nephrolithotomy
percutaneous surgery using nephroscope

Locations
Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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