Clinical trial NCT04261036: Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries
Official title: Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Study Protocol for a Randomized Double Blinded Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Catheter-Associated Urinary Tract Infection, Ascorbic Acid
Keywords: Vitamin C
CAUTI
Ascorbic Acid
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants who experienced clinically diagnosed and treated UTI.
timeFrame: 14 days
Secondary outcomes:
measure: Proportion of participants with asymptomatic bacteruria
timeFrame: 14 days
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
References:
citation: Foxman B, Cronenwett AE, Spino C, Berger MB, Morgan DM. Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial. Am J Obstet Gynecol. 2015 Aug;213(2):194.e1-8. doi: 10.1016/j.ajog.2015.04.003. Epub 2015 Apr 13.
citation: Ochoa-Brust GJ, Fernandez AR, Villanueva-Ruiz GJ, Velasco R, Trujillo-Hernandez B, Vasquez C. Daily intake of 100 mg ascorbic acid as urinary tract infection prophylactic agent during pregnancy. Acta Obstet Gynecol Scand. 2007;86(7):783-7. doi: 10.1080/00016340701273189.
citation: Carlsson S, Wiklund NP, Engstrand L, Weitzberg E, Lundberg JO. Effects of pH, nitrite, and ascorbic acid on nonenzymatic nitric oxide generation and bacterial growth in urine. Nitric Oxide. 2001 Dec;5(6):580-6. doi: 10.1006/niox.2001.0371.
citation: Trautner BW, Darouiche RO. Catheter-associated infections: pathogenesis affects prevention. Arch Intern Med. 2004 Apr 26;164(8):842-50. doi: 10.1001/archinte.164.8.842.
citation: Barbosa-Cesnik C, Brown MB, Buxton M, Zhang L, DeBusscher J, Foxman B. Cranberry juice fails to prevent recurrent urinary tract infection: results from a randomized placebo-controlled trial. Clin Infect Dis. 2011 Jan 1;52(1):23-30. doi: 10.1093/cid/ciq073.
citation: Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
citation: Wald HL, Ma A, Bratzler DW, Kramer AM. Indwelling urinary catheter use in the postoperative period: analysis of the national surgical infection prevention project data. Arch Surg. 2008 Jun;143(6):551-7. doi: 10.1001/archsurg.143.6.551.