Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 5971 for:    zero

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02304822
Recruitment Status : Unknown
Verified April 2017 by Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : December 2, 2014
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University

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.


Condition or disease Intervention/treatment Phase
Kidney Stones Drug: Multiple-dose of Ciprofloxacin prophylaxis Drug: Single-dose of Ciprofloxacin prophylaxis Drug: Zero-dose of Ciprofloxacin prophylaxis Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ciprofloxacin Prophylaxis in Retrograde Intrarenal Surgery: a Prospective Randomized Trail in Comparison of Multiple-, Single- and Zero-dose.
Actual Study Start Date : August 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Multiple-dose of ciprofloxacin prophylaxis
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
Multiple-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery and within 12 hours after surgery additionally
Other Name: Multiple-dose

Experimental: Single-dose of ciprofloxacin prophylaxis
Single-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery only
Drug: Single-dose of Ciprofloxacin prophylaxis
Single-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery only.
Other Name: Single-dose

Experimental: Zero-dose of ciprofloxacin prophylaxis
Zero-dose of ciprofloxacin prophylaxis with none intravenous ciprofloxacin either preoperatively or postoperatively
Drug: Zero-dose of Ciprofloxacin prophylaxis
Zero-dose of ciprofloxacin prophylaxis with none intravenous ciprofloxacin either preoperatively or postoperatively
Other Name: Zero-dose




Primary Outcome Measures :
  1. Postoperative SIRS [ Time Frame: 4 weeks after RIRS ]
    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.


Secondary Outcome Measures :
  1. Stone free rate [ Time Frame: 4 weeks after RIRS ]
    No observed fragments or fragments smaller than 2 mm was classified as stone free.

  2. Hemoglobin drop [ Time Frame: Within 24 hours after RIRS ]
    Hemoglobin drop is assessed by comparing the preoperative hemoglobin level with postoperative hemoglobin level which was detected within 24-hour after RIRS.

  3. Postopeartive hospital stay [ Time Frame: During the hospitalization ]
    Hospital stay was calculated from operation to discharge from hospital.

  4. Operative time [ Time Frame: intraoperatively ]
    The operative time was defined as the time from insertion of an endoscope into the urethra to the completion of stent placement.

  5. Hematuresis [ Time Frame: 4 weeks after RIRS ]
    Macroscopic hematuria was observed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304822


Contacts
Layout table for location contacts
Contact: Guohua Zeng, PH.D and M.D +86-13802916676 gzgyzgh@vip.tom.com

Locations
Layout table for location information
China, Guangdong
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510230
Contact: Guohua Zeng, Ph.D and M.D    +86 13802916676    gzgyzgh@vip.tom.com   
Principal Investigator: Guohua Zeng, Ph.D and M.D         
Sub-Investigator: Zhijian Zhao, M.D         
Sponsors and Collaborators
Guohua Zeng
Investigators
Layout table for investigator information
Study Chair: Guohua Zeng, PH.D and M.D The First Affiliated Hospital of Guangzhou Medical University

Layout table for additonal information
Responsible Party: Guohua Zeng, Vice-president of The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02304822     History of Changes
Other Study ID Numbers: MRER(32)2014
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Keywords provided by Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University:
kidney stones
retrograde intrarenal surgery
ciprofloxacin
prophylaxis
systemic inflammatory response syndrome

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Ciprofloxacin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors