- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157452
Prediction of Sepsis After Flexible Ureteroscopy
November 6, 2019 updated by: Li Cong, Tongji Hospital
Prediction of Sepsis After Flexible Ureteroscopy in Patients With Proximal Ureteral Stone by Using Preoperative Factors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
759
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients are enrolled in Wuhan Tongji Hospital from January 2012 to December 2018.
Patient data is collected from institutional medical record archives.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
proximal ureteral stone patient
|
flexible ureteroscopy is used to removed the stone.
If a double-J stent was inserted pre-operatively, it was removed at the beginning of surgery.
Rigid ureteroscopy was routinely used for ureteral dilatation before fURS.
A 0.035 mm guidewire was advanced through the urethral and ureteral meatuses to the renal pelvis under direct rigid ureteroscope vision.
A 14-Fr ureteral access sheath (Cook Medical, Bloomington, IN) was then passed over the wire to the ureteropelvic junction, and 7.5-Fr fURS (Flex-X2, Karl Storz, Germany) was performed through the sheath.
Intrarenal pressure was stabilized by a pressure-sensitive pump (Shenda Medical, China).
Holmium: yttrium-aluminum-garnet laser was used to fragment the stones.
After lithotripsy, 6-Fr double-J stent was routinely inserted in all cases for 2-4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complication-sepsis
Time Frame: within 48 hour after surgery
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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
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within 48 hour after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
October 20, 2019
Study Registration Dates
First Submitted
November 6, 2019
First Submitted That Met QC Criteria
November 6, 2019
First Posted (Actual)
November 8, 2019
Study Record Updates
Last Update Posted (Actual)
November 8, 2019
Last Update Submitted That Met QC Criteria
November 6, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019S1035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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