Prediction of Sepsis After Flexible Ureteroscopy

Sepsis Clinical Trial

Official title:

Prediction of Sepsis After Flexible Ureteroscopy in Patients With Proximal Ureteral Stone by Using Preoperative Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04157452
• Other study ID #: 2019S1035
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: October 20, 2019

Study information

• Verified date: November 2019
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: October 20, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Surgery--Complications
• Toxemia
• Urolithiasis

Intervention

Procedure:
• flexible ureteroscopy
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.

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	complication-sepsis	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	within 48 hour after surgery