Prediction of Sepsis After Percutaneous Nephrolithotomy

• Sponsor: Tongji Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04340037
• Collaborator: (none)
• Enrollment: 745
• Location: 1
• Actual Duration (Months): 11.7
• Patients Per Site Per Month: 63.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Nephrolithotomy; Infection; Urolithiasis; Albumin Globulin Ratio	Procedure: percutaneous nephrolithotomy

Study Design

• Study Type: Observational
• Actual Enrollment: 745 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: A Pre-operative Nomogram for Sepsis After Percutaneous Nephrolithotomy Treating Solitary, Unilateral, and Proximal Ureteral Stones
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Feb 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. sepsis [within 48 hour after surgery]

   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

Eligibility Criteria

Criteria

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

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030

Sponsors and Collaborators

• Tongji Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Cong, Professor, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT04340037
• Other Study ID Numbers: 2019S1035v2
• First Posted: Apr 9, 2020
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

• 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
• Additional relevant MeSH terms: Urolithiasis

Study Results

No Results Posted as of Apr 9, 2020