Addition of somatostatin-14 to a standard Total Parenteral Nutrition-mixture in the treatment of fistulae : a clinical, double-blind, randomised, cross-over study
Faculty of Medicine and Health Sciences
Acta gastro-enterologica belgica. - Bruxelles, 1946 - 1995
, p. 246-249
University of Antwerp
Background / study aims : Somatostatin and total parenteral nutrition (TPN) are routinely used in the treatment of pancreatic and enterocutaneous fistulae. The objective of this clinical randomised cross-over study was to investigate the serum levels of somatostatin infused alongside TPN by a separate intravenous line, and when it had been added to the TPN mixture. Patients / methods : The subjects were recruited by the treating physicians and the nutrition nurses. From the patients who started the study, no one dropped out. Ten patients were treated with a standard TPN mixture and somatostatin 6 mg/day. Patients were randomised to two possible regimens : 'somatostatin plus TPN somatostatin separately - somatostatin plus TPN' or 'somatostatin separately - somatostatin plus TPN - somatostatin separately'. Each regimen consisted of 3 x 3 days of therapy, during which, serum levels of somatostatin were measured daily. Pre- and post-treatment samples were also analysed. Results : When somatostatin was infused separately, the mean serum level was 884.8 pg/ml (SD: 557.3; range: 54-1900). When added to TPN, the mean serum level was 807.5 pg/ml (SD: 505.8; range 162-2279) (p value of difference = 0,473). The mean pretreatment level was 17.1 pg/ml (SD : 7.5; range : 8-33), and post-treatment was 32.8 pg/ml (SD : 26.5 range : 16-97). Conclusions : These results demonstrate that serum levels of somatostatin are similar in both treatment regimens and therefore may be added to a TPN mixture. Sponsorship: This study was performed with an unconditional Educational Grant from UCB-Belgium. The authors did not have any conflict of interest in UCB-Belgium.