Evaluation of clinical safety and beneficial effects of a fish oil containing lipid emulsion (Lipoplus, MLF541): data from a prospective, randomized, multicenter trial.
OBJECTIVE
To prove safety and effectiveness of a lipid emulsion enriched with n-3 fatty acids from fish oil (Lipoplus) within the setting of parenteral nutrition of patients after major abdominal surgery and to determine whether there are effects on outcome parameters.


METHODS
Prospective, randomized, double-blind, multicenter trial.


METHODS
University and surgical teaching hospitals.


METHODS
After obtaining informed consent, 256 patients undergoing major abdominal surgery were randomized. Parameters of safety, effectiveness, and outcome were routine laboratory parameters, complication rates, length of stay in the intensive care unit, and length of hospital stay. In addition we determined in patient subgroups of 30 patients each, the changes of the content of selected long-chain polyunsaturated fatty acids, the leukotriene synthetic capacity and the antioxidant alpha-tocopherol.


METHODS
Participating patients were randomized to receive either Lipoplus (group I; n = 127 patients) or Intralipid (group II; n = 129 patients). Parenteral nutrition was initiated immediately after surgery and ended on day 5 after surgery.


RESULTS
No significant differences between groups I and II were observed when comparing routine laboratory parameters during the perioperative period. Plasma levels of eicosapentaenoic acid, leukotriene B5, and antioxidant content were significantly increased in group I. Furthermore, there was a significantly shorter length of hospital stay of approximately 21% (17.2 vs. 21.9 days; p = .0061) in group I.


CONCLUSIONS
Our findings indicate that the administration of Lipoplus in the postoperative period after major abdominal surgery is safe and results in a significantly shorter length of hospital stay. Administration of n-3 polyunsaturated fatty acids in the postoperative period can be considered a valuable choice for patients requiring parenteral nutrition after major abdominal surgery.
Wichmann
Matthias W
MW
Department of Surgery, Ludwig-Maximilians University, Klinikum Grosshadern, Marchioninistrasse 15, 81377 Munich, Germany. Matthias.Wichmann@med.uni-muenchen.de
Thul
Paul
P
Czarnetzki
Hans-Dieter
HD
Morlion
Bart J
BJ
Kemen
Matthias
M
Jauch
Karl-Walter
KW
D000005:Abdomen / Q000601:surgery; D000328:Adult; D000368:Aged; D000596:Amino Acids / Q000097:blood; D003422:Critical Care; D015118:Eicosapentaenoic Acid / Q000097:blood; D005217:Fat Emulsions, Intravenous; D005231:Fatty Acids, Unsaturated / Q000097:blood; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage* / Q000009:adverse effects; D005858:Germany; D017052:Hospital Mortality; D006801:Humans; D007362:Intensive Care Units; D007902:Length of Stay; D015289:Leukotrienes / Q000097:blood; D008297:Male; D008875:Middle Aged; D010289:Parenteral Nutrition, Total; D010743:Phospholipids / Q000097:blood; D011182:Postoperative Care; D011183:Postoperative Complications / Q000097:blood / Q000401:mortality; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D024502:alpha-Tocopherol / Q000097:blood
D000596:Amino Acids; D005217:Fat Emulsions, Intravenous; D005231:Fatty Acids, Unsaturated; D005395:Fish Oils; D015289:Leukotrienes; D010743:Phospholipids; D015118:Eicosapentaenoic Acid; D024502:alpha-Tocopherol