Catheter-Associated Urinary Tract Infection, Ascorbic Acid
Conditions
Keywords
Vitamin C, CAUTI, Ascorbic Acid
Brief summary
This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.
Interventions
1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.
OTHERPlacebo
Placebo pills for 14 days post-op after an elective gynecological surgery.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Vitamin C and Placebo pills will be blindly labeled and assorted in opaque containers in the Pharmacy department according to a computer generated list that allocated random assignment of vitamin C or placebo to a 200 positions (serial numbers from 1 to 200). The research assistant in charge of the recuitment will not be aware of the content of each opaque container and would be providing them to patients according to the order in which they are recruited starting with container number 1, then 2 and so on. The primary care provider and the investigators are blinded as well as they are not aware of the assignment of each recruited patient to placebo vs interventional arm. It is only upon completion of data collection that results would be compared with the randomized generated list in order to link the recruited patients and their collected data with their original assignment to placebo vs intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC).
Exclusion criteria
* Any women with the following: 1. Nephrolithiasis 2. Congenital anomaly or neurogenic bladder 3. Allergy to ascorbic acid 4. Who require therapeutic anticoagulant medicine during the 6 weeks after surgery 5. Surgery did involve a fistula repair or a vaginal mesh removal 6. Positive Urinalysis in the PAU 7. Recurrent UTI's 8. Diabetes 9. G6PD 10. Hemochromatosis 11. Renal disorders Patients already taking Vitamin C supplementation will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who experienced clinically diagnosed and treated UTI. | 14 days | Urinary tract infection is diagnosed by a positive urine culture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with asymptomatic bacteruria | 14 days | Participants with positive urine culture but no symptoms |
Countries
Lebanon
Outcome results
None listed