Comparison of the Effectiveness of ciprofloxacin, ceftriaxone, and gentamicin for preventing of bacteriuria , febrile urinary tract infection and systemic inflammatory response syndrome after transurethral lithotripsy
Design
single-blind randomized controlled trial
Settings and conduct
the first group, 88 patients use 1 g ceftriaxone 30 minutes before surgery. In the second group, 88 patients are injected with 400mg ciprofloxacin 30 minutes before surgery. And in the third group, 88 patients are injected 2 mg/kg gentamicin 30 minutes before surgery.
In Shahid Rahmon Hospital, Yazd
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Patients with middle and distal ureteral calculi with negetive urine culture that are going to undergo TUL (the maximum diameter of the stone is <2 cm)
2. Age 18 to 65 years old.
Exlusion criteria
1. Asymptomatic patients with colony count ≥ 10 5 CFU/mL or a symptomatic UTI with colony count ≥ 10 3 CFU/mL
2. Patients with any catheter.
3. Patients with preoperative fever (body temperature ≥ 38°C).
4. Patients with a history of diabetes.
5. Patients with immunocompromised diseases or using immunosuppressive drugs.
6. Patients with abnormal renal function.
7. Patients who have received antimicrobial treatment within two weeks before enrollment.
8. Pregnant or breastfeeding women.
9. Patients who are allergic to our research drugs.
Intervention groups
The enrolled patients are randomly divided into 3 different antibiotics groups according to the random number table. The patients are randomly allocated, using a randomization ratio of 1:1:1.
Main outcome variables
Determining the most effective prophylactic antibiotic for TUL with the lowest bacteriuria , fUTI and SIRS after it
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231031059918N1
Registration date:2023-11-13, 1402/08/22
Registration timing:prospective
Last update:2023-11-13, 1402/08/22
Update count:0
Registration date
2023-11-13, 1402/08/22
Registrant information
Name
nazanin akhavan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3523 6600
Email address
nazanin1379akhavan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-25, 1402/09/04
Expected recruitment end date
2024-11-24, 1403/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Ciprofloxacin, Ceftriaxone, and Gentamicin for preventing bacteriuria after transurethral lithotripsy (TUL)
Public title
Comparing the effectiveness of Ciprofloxacin, Ceftriaxone, and Gentamicin for preventing bacteriuria after transurethral lithotripsy (TUL)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with middle and distal ureteral calculi with negetive urine culture that are going to undergo TUL (the maximum diameter of the stone is <2 cm)
Age 18 to 65 years old.
Exclusion criteria:
Asymptomatic patients with colony count ≥ 10 5 CFU/mL or a symptomatic UTI with colony count ≥ 10 3 CFU/mL
Patients with any catheter.
Patients with preoperative fever (body temperature ≥ 38°C)
Patients with a history of diabetes.
Patients with immunocompromised diseases or using immunosuppressive drugs
Patients with abnormal renal function
Patients who have received antimicrobial treatment within two weeks before enrollment
Pregnant or breastfeeding women
Patients who are allergic to our research drugs.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
264
Randomization (investigator's opinion)
Randomized
Randomization description
Allocating the samples to the intervention groups will be through the creation of a random sequence using the permutation block method using the Random Allocation software and a computer-generated list of random numbers. Therefore it is done by a person not involved in the study and randomized codes are kept in sealed envelopes and open at the time of patient recruitment .
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not know which of the 3 antibiotics they will receive. However, Principal investigator, health care personnel and data collection officer will be informed.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine - Shahid Sadougi University of Medical Sciences, Yazd (Research Ethics Committee
Street address
Jomhouri Boulevard, Alley 56, Seventh Alley, Second Dead End, Second House
City
yazd
Province
Yazd
Postal code
8917956195
Approval date
2023-11-08, 1402/08/17
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.229
Health conditions studied
1
Description of health condition studied
Comparing the effectiveness of ciprofloxacin, ceftriaxone, and gentamicin for preventing bacteriuria after transurethral lithotripsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Significant bacteriuria was defined asymptomatic patients with colony count ≥ 10 5 CFU/mL or a symptomatic UTI with colony count ≥ 10 3 CFU/mL.
Timepoint
After 48 hour of surgery, routine urine tests and urine bacterial cultures, will be recorded.
Method of measurement
Routine urine tests and urine bacteria culture are done in the Rahnemoun hospital laboratory.
2
Description
Febrile urinary tract infection (fUTI) is defined as a body temperature of 38.5 C accompanying urinary tract infection after surgery.
Timepoint
After 48 hour of surgery
Method of measurement
body temperature by thermometer will be recorded.
3
Description
• SIRS criteria defined by: WBC < 4000 or > 12000 , heart rate > 90 per minute , temperature < 36 C or > 38 C , respiratory rate >20 or pCO2 < 32 . (Presence of two or more of these criteria is accepted as SIRS.)
Timepoint
After 48 hour of surgery
Method of measurement
Routine urine tests and urine bacteria culture are done in the Rahnemoun hospital laboratory.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 88 patients use 1 g ceftriaxone 30 minutes before surgery
Category
Treatment - Drugs
2
Description
Intervention group: 88 patients are injected with 400mg ciprofloxacin 30 minutes before surgery.
Category
Treatment - Drugs
3
Description
Intervention group: 88 patients are injected 2 mg/kg gentamicin 30 minutes before surgery.