Safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART) in refractory ascites: Post-marketing surveillance results

PLoS One. 2017 May 16;12(5):e0177303. doi: 10.1371/journal.pone.0177303. eCollection 2017.

Abstract

We performed post-marketing surveillance to evaluate the safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART). In total, 356 CART sessions in 147 patients at 22 centers were performed. The most common primary disease was cancer (128 cases, 300 sessions). Mean amount of ascites collected was 3.7 L, and mean concentration ratio was 9.2. Mean amount of reinfused protein was 67.8 g (recovery rate, 72.0%). Performance status, dietary intake, urine volume, body weight and abdominal circumference were significantly improved after CART. Body temperature increased significantly, by 0.3°C on average. Concomitant steroids and/or NSAIDs use before reinfusion was significantly and negatively associated with increases in body temperature. Most adverse events were fever and chills. This study examined a large number of patients compared with previous studies, and showed that CART is an effective and relatively safe treatment for refractory ascites, such as malignant ascites.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Ascites / etiology
  • Ascites / pathology*
  • Ascites / therapy*
  • Ascitic Fluid / pathology*
  • Blood Pressure
  • Body Temperature
  • Female
  • Fluid Therapy / adverse effects
  • Fluid Therapy / methods*
  • Humans
  • Infusions, Parenteral
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing
  • Treatment Outcome
  • Young Adult

Grants and funding

The funder provided support in the form of salaries for authors AI, HO, RK, NT, TN, TK, and YM. This study was performed on the basis of a post-marketing surveillance (PMS) in which Asahi Kasei Medical, Co., Ltd., the funder of this study, planned and performed the survey as is usual in PMS performed in Japan. In this regard, the funder inevitably had significant roles in the study design, data collection and the analyses of the collected data, and decision to publish. The funder had made a committee for this survey to maintain the transparency. The members of the committee were the experts of CART procedures, NH, T. Ishihara, T. Inoue, KI, TU, TY, T. Ito, and MK, and they have not been the employee of the funder. The committee made the final decision of the analytic methods, the review of the results, and the completion of this manuscript. On the other hand, MK is the president of Medical Corporation, Kenseikai. The corporation, however, does not have any role in this study and manuscript.