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

Primary Purpose

Nephrolithiasis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ciprofloxacin
Levofloxacin
Sponsored by
Diaa Eldin Taha Ramadan Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kafrelsheikh faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ciprofloxacin

levofloxacin

Arm Description

ciprofloxacin tablets

levofloxacin tablets

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine
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.
predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.
assess the risk factors for SIRS and sepsis in PCNL.

Full Information

First Posted
April 18, 2020
Last Updated
March 1, 2021
Sponsor
Diaa Eldin Taha Ramadan Mohamed
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1. Study Identification

Unique Protocol Identification Number
NCT04374188
Brief Title
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy
Official Title
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Diaa Eldin Taha Ramadan Mohamed

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Efficacy of ciprofloxacin therapy in sepsis avoidance.
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ciprofloxacin
Arm Type
Active Comparator
Arm Description
ciprofloxacin tablets
Arm Title
levofloxacin
Arm Type
Active Comparator
Arm Description
levofloxacin tablets
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Other Intervention Name(s)
quinolones
Intervention Description
drug adminstration to ameliorate sepsis incidence
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
quinolones
Intervention Description
levofloxacin pill
Primary Outcome Measure Information:
Title
Effect of ciprofloxacin versus levofloxacin duration before PCNL
Description
To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine
Description
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.
Time Frame
12 months
Title
predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.
Description
assess the risk factors for SIRS and sepsis in PCNL.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diaa Eldin Taha, MD
Phone
01008531384
Email
drdiaaeldin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hossam Nabeeh, MD
Email
dr_hossam_nabeeh@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diaa Eldin Taha, MD
Organizational Affiliation
Lecturer of urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh faculty of medicine
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diaa ELDIN Taha, MD
Phone
01008531384
Email
drdiaaeldin@gmail.com
First Name & Middle Initial & Last Name & Degree
Hossam Nabeeh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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