Kan C-vitamin forebygge urinveisinfeksjoner hos ryggmargsskadde? : - design av en studieprotokoll

Abstract

INTRODUCTION: Urinary tract infection (UTI) is a major problem in patients with a spinal cord injury (SCI) who have lost control over their bladder function. UTI is a common cause of sepsis in these patients, which leads to high mortality and morbidity rates. There is an urgent need of effective prophylaxis in this group of patients, especially non-antibiotic prophylaxis, that does not give rise to resistance against antibiotics. Vitamin C is commonly used, but there is a lack of documentation of efficiency.

GOAL: To design, get approval, and to describe the development of a randomized, controlled clinical trial (RCT) that can determine if vitamin C is an efficient prophylaxis for UTI in patients with SCI. This paper should also be used as an example of how to design a RCT, through comments of the process concerning the decisions and the applications. RESULTS: The study is approved and started.

CONCLUSION: To design a study demands a great deal of knowledge before it will be approved by the Regional ethical committee, the Norwegian medicines agency and by the Data protection commissioner in the responsible hospital. The study also has to be registered in a database over clinical studies. When all the plans are ready, what remains as the main challenge is the recruitment of patients.