Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009
Prospective, randomized trial of two different modalities of flushing central venous catheters in pediatric patients with cancer.
Клиническое исследование III фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Cesaro Simone, Tridello Gloria, Cavaliere Mara, Magagna Laura, Gavin Patrizia, Cusinato Riccardo, Zadra Nicola, Franco Zanon Giovanni, Zanesco Luigi, Carli Modesto
Аннотация
PURPOSE: There are limited prospective data on whether the method of flushing affects the complication rate of tunnelled central venous catheters (CVCs).
PATIENTS AND METHODS: During a 25-month period, 203 pediatric patients who had newly placed Broviac-Hickman CVCs were randomly assigned to standard flushing with heparin solution or to experimental flushing with normal saline via a positive-pressure cap.
RESULTS: Two hundred twenty-one complications were recorded among 75,249 CVC-days (2.94 per 1,000 CVC-days). A higher incidence of CVC occlusion (83 v 41 episodes; P = .0002) and bacteremia (24 v 9; P = .01) were found in the experimental arm. The cumulative probability of developing at least one CVC complication was higher in the experimental arm than in the standard arm (65.1% [95% CI, 55% to 75%] v 43.8% [95% CI, 34% to 54%], respectively; P = .01). No difference was found in either the cause or the frequency of premature removal of CVCs between the two study arms. After a median follow-up of 360 days (range, 4 to 1,073), CVC survival was similar: 77% (95% CI, 66% to 84%) for the experimental arm and 69% (95% CI, 53% to 80%) for the standard arm (P = .7). The factors associated with the occurrence of CVC complication were a diagnosis of leukemia/lymphoma, double-lumen CVC, and experimental flushing. The only factor significantly associated with premature removal of a CVC was a diagnosis of leukemia/lymphoma (hazard rate, 2.3; 95% CI, 1.1 to 4.7).
CONCLUSION: An increased complication rate was found with normal saline flushing, but additional investigation is warranted to clarify whether it is related to saline use or to once-a-week flushing.
PATIENTS AND METHODS: During a 25-month period, 203 pediatric patients who had newly placed Broviac-Hickman CVCs were randomly assigned to standard flushing with heparin solution or to experimental flushing with normal saline via a positive-pressure cap.
RESULTS: Two hundred twenty-one complications were recorded among 75,249 CVC-days (2.94 per 1,000 CVC-days). A higher incidence of CVC occlusion (83 v 41 episodes; P = .0002) and bacteremia (24 v 9; P = .01) were found in the experimental arm. The cumulative probability of developing at least one CVC complication was higher in the experimental arm than in the standard arm (65.1% [95% CI, 55% to 75%] v 43.8% [95% CI, 34% to 54%], respectively; P = .01). No difference was found in either the cause or the frequency of premature removal of CVCs between the two study arms. After a median follow-up of 360 days (range, 4 to 1,073), CVC survival was similar: 77% (95% CI, 66% to 84%) for the experimental arm and 69% (95% CI, 53% to 80%) for the standard arm (P = .7). The factors associated with the occurrence of CVC complication were a diagnosis of leukemia/lymphoma, double-lumen CVC, and experimental flushing. The only factor significantly associated with premature removal of a CVC was a diagnosis of leukemia/lymphoma (hazard rate, 2.3; 95% CI, 1.1 to 4.7).
CONCLUSION: An increased complication rate was found with normal saline flushing, but additional investigation is warranted to clarify whether it is related to saline use or to once-a-week flushing.