Comparison of Multiple-, Single- and Zero-dose of Ciprofloxacin Prophylaxis in Retrograde Intrarenal Surgery

NCT02304822 | Unknown DMC

• 1 other identifier: MRER（32）2014
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the postoperative systemic inflammatory response syndrome (SIRS) rates undergoing retrograde intrarenal surgery (RIRS) after multiple-, single-, zero-dose of ceftriaxone prophylaxis in a prospective randomized trail. The investigators will enroll 450 patients who are candidates for RIRS in the investigators study. By simple random sampling technique, patients will be assigned to three groups (multiple-, single-, zero-dose of ceftriaxone prophylaxis,respectively). In addition to the difference of usage of ciprofloxacin prophylaxis, the rest of the procedure is the same in all three groups.The end point of the study is the comparison of outcome of procedure including SIRS rate, stone free rate (SFR), operation time, length of stay,and hematuresis.

Conditions

Kidney Stones

Keywords

kidney stones; retrograde intrarenal surgery; ciprofloxacin; prophylaxis; systemic inflammatory response syndrome

Outcome Measures

Primary Outcomes (1)

• Postoperative SIRS

  White blood count \< 4000 or \>12000 cells/mm3, heart rate \>90 beats per minute, temperature \<36°C or \>38°C, respiratory rate \> 20 breaths/min. Presence of two or more of these criteria was accepted as SIRS.

  4 weeks after RIRS

Secondary Outcomes (5)

• Stone free rate

  4 weeks after RIRS

• Hemoglobin drop

  Within 24 hours after RIRS

• Postopeartive hospital stay

  During the hospitalization

• Operative time

  intraoperatively

• Hematuresis

  4 weeks after RIRS

Study Arms (3)

Multiple-dose of ciprofloxacin prophylaxis

ACTIVE COMPARATOR

Multiple-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery and within 12 hours after surgery additionally

Drug: Multiple-dose of Ciprofloxacin prophylaxis

Single-dose of ciprofloxacin prophylaxis

EXPERIMENTAL

Single-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery only

Drug: Single-dose of Ciprofloxacin prophylaxis

Zero-dose of ciprofloxacin prophylaxis

EXPERIMENTAL

Zero-dose of ciprofloxacin prophylaxis with none intravenous ciprofloxacin either preoperatively or postoperatively

Drug: Zero-dose of Ciprofloxacin prophylaxis

Interventions

Multiple-dose of Ciprofloxacin prophylaxis DRUG

Multiple-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery and within 12 hours after surgery additionally

Also known as: Multiple-dose

Multiple-dose of ciprofloxacin prophylaxis

Single-dose of Ciprofloxacin prophylaxis DRUG

Single-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery only.

Also known as: Single-dose

Single-dose of ciprofloxacin prophylaxis

Zero-dose of Ciprofloxacin prophylaxis DRUG

Zero-dose of ciprofloxacin prophylaxis with none intravenous ciprofloxacin either preoperatively or postoperatively

Also known as: Zero-dose

Zero-dose of ciprofloxacin prophylaxis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Decision to performed RIRS to treat the kidney stones
• American society of Anesthesiology (ASA) score 1 and 2
• Kidney stones of diameter \< 2.5 cm

You may not qualify if:

• Positive preoperative urine culture
• Pyruria (\>10 white blood cells per high-power field)
• Antibiotics treatment of UTI in the last 4 weeks
• Immunocompromised
• Diabetes mellitus
• Allergy to quinolone
• Existing ureteric stents
• Turbid pelvic urine or purulent stone surface observed intraoperatively
• Ureteral stricture, renal or urethral deformity

Sponsors & Collaborators

• Guohua Zeng: lead

Study Sites (1)

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

RECRUITING

Related Publications (1)

• Zhao Z, Fan J, Sun H, Zhong W, Zhu W, Liu Y, Wu W, de la Rosette J, Del Pilar Laguna Pes M, Zeng G. Recommended antibiotic prophylaxis regimen in retrograde intrarenal surgery: evidence from a randomised controlled trial. BJU Int. 2019 Sep;124(3):496-503. doi: 10.1111/bju.14832. Epub 2019 Jun 20.

  PMID: 31136070 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes; Shock

Study Officials

• Guohua Zeng, PH.D and M.D

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Guohua Zeng, PH.D and M.D

CONTACT

+86-13802916676; gzgyzgh@vip.tom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-president of The First Affiliated Hospital of Guangzhou Medical University

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 2, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

CN (1)