A multi-center prospective study randomizing the use of fat emulsion in intensive glucose control after allogeneic hematopoietic stem cell transplantation using a myeloablative conditioning regimen.
BACKGROUND & AIMS
Although parenteral nutrition (PN) is often used after allogeneic hematopoietic stem cell transplantation (allo-HSCT), there is controversy regarding PN management, for instance in the use of fat emulsion and glucose control (GC). To clarify these issues, we conducted a multi-center prospective study with intensive GC, randomizing the use of fat emulsion after allo-HSCT using a myeloablative conditioning regimen.


METHODS
The primary endpoint was the cumulative incidence of documented infectious disease, namely bacterial and fungal infection, at day 100 after allo-HSCT. Between August 2007 and March 2012, we enrolled 81 patients at 5 centers. Excluding 5 ineligible patients, 76 patients received the protocol treatment. The target fasting glucose level was 80-110 mg/dL.


RESULTS
The median follow-up of surviving patients was 1796 days. The cumulative incidences of documented infectious disease at day 100 were 16% (95% confidence interval [CI] 6-29%) in the no-fat group and 19% (95% CI 8-32%) in the fat group, indicating no significant difference. The mean glucose level at 28 days after allo-HSCT was 107 mg/dL in the no-fat group and 111 mg/dL in the fat group. Grade 3 hyperglycemia (>250 mg/dL) and grade 3 hypoglycemia (<40 mg/dL) occurred in 4 patients each (5.3%). Overall survival and non-relapse mortality rates at 4 years were 75% and 11% in the no-fat group and 69% and 8% in the fat group, respectively.


CONCLUSIONS
Irrespective of the use of fat emulsion, the long-term clinical outcomes of the enrolled patients were favorable under intensive GC. To further clarify the benefits of GC after allo-HSCT, a prospective study randomizing the level of GC is warranted.
['Fuji|Shigeo|S|', 'Kim|Sung-Won|SW|', 'Kamiya|Shigemi|S|', 'Nakane|Takahiko|T|', 'Matsumoto|Kenji|K|', 'Onishi|Yasushi|Y|', 'Yakushijin|Kimikazu|K|', 'Yamazaki|Etsuko|E|', 'Hino|Masayuki|M|', 'Kurosawa|Saiko|S|', 'Yoshimura|Ken-Ichi|KI|', 'Fukuda|Takahiro|T|']
D000328:Adult D001786:Blood Glucose D003422:Critical Care D005217:Fat Emulsions, Intravenous D005260:Female D005500:Follow-Up Studies D018380:Hematopoietic Stem Cell Transplantation D006801:Humans D008297:Male D008875:Middle Aged D010288:Parenteral Nutrition D011446:Prospective Studies D016019:Survival Analysis D019172:Transplantation Conditioning D014184:Transplantation, Homologous D016896:Treatment Outcome D055815:Young Adult
Fat emulsion Glucose control Hyperglycemia Allogeneic transplantation