Cranberry as a Strategy for Preventing CAUTI Post Gynecologic Surgery

蔓越莓作为预防妇科手术后 CAUTI 的策略

基本信息

批准号：
8136110
负责人：
BETSY FOXMAN
金额：
$ 23.09万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-01 至 2013-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8136110
关键词：
Accounting Adherence Am 80 Antibiotic Prophylaxis Antibiotic Resistance Antibiotic Therapy Antibiotics Bladder Catheterization Catheters Cells Child Ciprofloxacin Clinical Trials Complication Conflict (Psychology)Cotrimoxazole Coupled Cranberries Development Diagnosis Double-Blind Method Effectiveness Enrollment Escherichia coli Feasibility Studies Future Genitourinary System Infection Goals Gram-Negative Bacteria Gram-Positive Bacteria Gynecologic Surgical Procedures Hospitals Hour Hygiene Hysterectomy Incidence Infection prevention Intake Intervention Juice Laparoscopic Surgical Procedures Metronidazole Neurogenic Bladder Nosocomial Infections Operative Surgical Procedures Oral Organism Outcome Patients Pelvic floor structure Pilot Projects Placebo Control Placebos Population Postoperative Period Prevalence Prevention Prevention strategy Preventive Intervention Prophylactic treatment Randomized Relative (related person)Research Design Resistance Risk Sample Size Specific qualifier value Spinal cord injury patients Tablets Therapeutic Time Urinary tract Urinary tract infection Urine Uropathogen Visit Woman antimicrobial arm capsule catheter associated UTI high risk improved instrumentation pathogen prevent prophylactic public health relevance standard of care treatment as usual

项目摘要

DESCRIPTION (provided by applicant): Infections of the genitourinary ract account for ~ 40% of all hospital- acquired infections; of these, 80% are related to urinary tract instrumentation and catheterization. Catheter associated urinary tract infection (CAUTI) is a common complication of patients undergoing gynecologic surgery, with 10-27% of gynecologic surgery patients developing a UTI in the post operatory period - despite prophylactic antibiotic therapy. Further, UTI pathogens are increasingly resistant to antibiotics. Most CAUTI prevention strategies have focused on modifying the catheter, improving hygiene associated with catheter insertion, and using prophylactic antibiotics. Cranberry products provide an alternative; they inhibit adherence of E. coli and other gram-negative bacteria to uroepithelial cells, (and likely of gram positive bacteria as well), and are known to reduce UTI incidence among non-catheterized populations. Thus, cranberry potentially provides alternative means for preventing CAUTI that also would reduce prophylactic and therapeutic antibiotic use. To date, the use of cranberry products for the prevention of UTI among catheterized post operator gynecological patients remains an unexplored potential intervention. We propose a randomized, double blind, placebo-controlled pilot clinical trial of 200 surgical gynecological patients. Our overall goal is to determine the effect of taking cranberry capsules on reducing the rate of post operatory CAUTI among surgical gynecological patients. This pilot study will have 2 arms: 1) Cranberry capsules equivalent to 8 oz of cranberry juice (CJ) twice a day 2) Placebo capsules twice a day. The results of this study will help us to increase our understanding the effect of cranberry on reducing the prevalence of post gynecologic surgery CAUTI, aiming for a large scale clinical trial in the future. PUBLIC HEALTH RELEVANCE: Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (CAUTI) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery, Cranberry products, provide alternative means for preventing CAUTI and could result in decreased use of antimicrobials. In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to take either cranberry capsules or placebo. The low risk of harm associated with using cranberry to reduce UTI coupled with its potential benefit makes it a desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot /feasibility study will prepare us for the conduct of a large scale clinical trial.

描述（由申请人提供）：泌尿生殖器RACT的感染约占所有医院感染的40％；其中80％与尿路仪器和导管插入术有关。导管相关的尿路感染（CAUTI）是接受妇科手术的患者的常见并发症，尽管有预防性抗生素疗法，但在操作后，有10-27％的妇科手术患者在操作后开发UTI。此外，UTI病原体越来越对抗生素具有抗药性。大多数CAUTI预防策略都致力于修饰导管，改善与导管插入相关的卫生以及使用预防性抗生素。蔓越莓产品提供了替代品；它们抑制了大肠杆菌和其他革兰氏阴性细菌对近地上细胞的粘附（也可能是革兰氏阳性细菌），并且已知可以降低非渗透群体中的UTI发生率。因此，蔓越莓有可能提供预防cauti的替代方法，从而减少预防性和治疗性抗生素的使用。迄今为止，在导管后操作员妇科患者中使用蔓越莓产品预防UTI仍然是未开发的潜在干预措施。我们提出了200名手术妇科患者的随机，双盲，安慰剂对照的试验临床试验。我们的总体目标是确定服用蔓越莓胶囊对降低手术妇科患者手术后CAUTI率的影响。这项试点研究将有2个臂：1）每天两次两次安慰剂胶囊每天两次，相当于8盎司的蔓越莓汁（CJ）。这项研究的结果将有助于我们增加理解蔓越莓对降低妇科手术后CAUTI患病率的影响，旨在将来进行大规模的临床试验。公共卫生相关性：大约10-27％的接受妇科手术的患者在操作后期发展了导管相关的尿路感染（CAUTI），因为膀胱导管是妇科手术中的一种常见实践，在妇科手术中提供了替代手段，可防止Cauti的替代手段并可能导致使用抗菌素的使用减少。在这项试点研究中，我们将在妇科手术后进行200名妇女，然后将其随机服用酸果蔓胶囊或安慰剂。与使用Cranberry减少UTI相关的危害风险的低风险以及其潜在的益处使其成为预防CAUTI的理想干预措施。这项试验 /可行性研究的行为 /结果将使我们为进行大规模临床试验做好准备。