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Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Sponsor
Diaa Eldin Taha Ramadan Mohamed (Other)
Overall Status
Recruiting
CT.gov ID
NCT04374188
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Efficacy of ciprofloxacin therapy in sepsis avoidance.Efficacy of ciprofloxacin therapy in sepsis avoidance.
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ciprofloxacin

ciprofloxacin tablets

Drug: Ciprofloxacin
drug adminstration to ameliorate sepsis incidence
Other Names:
  • quinolones

    		•
    Active Comparator: levofloxacin

    levofloxacin tablets

    Drug: Levofloxacin
    levofloxacin pill
    Other Names:
  • quinolones

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of ciprofloxacin versus levofloxacin duration before PCNL [12 months]

      To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL.

    Secondary Outcome Measures

    1. differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine [12 months]

      Compare the difference between C&S of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone, in predicting the upper urinary tract infection and urosepsis.

    2. predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL. [12 months]

      assess the risk factors for SIRS and sepsis in PCNL.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Patient 18 years or older

    • Stones ≥ 2 cm and/or mild to moderate hydronephrosis

    • Sterile mid urine stream

    Exclusion Criteria:

    • Patients with a stent, nephrostomy tube or indwelling catheter

    • Renal failure

    • Fever before surgery

    • Previous manipulation/procedure

    • Concomitant bladder stone or tumour

    • Patients with active UTI

    • Contralateral renal/ureteric stone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kafrelsheikh faculty of medicine Kafr Ash Shaykh Kafrelsheikh Egypt

    Sponsors and Collaborators

    • Diaa Eldin Taha Ramadan Mohamed

    Investigators

    • Principal Investigator: Diaa Eldin Taha, MD, Lecturer of urology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diaa Eldin Taha Ramadan Mohamed, Lecturer of urology, Kafrelsheikh University
    ClinicalTrials.gov Identifier:
    NCT04374188
    Other Study ID Numbers:
    • RS/19.23
    First Posted:
    May 5, 2020
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Mar 1, 2021
    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
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Nephrolithiasis
    Kidney Calculi
    Ciprofloxacin
    Levofloxacin
    Ofloxacin

    Study Results

    No Results Posted as of Mar 3, 2021