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| Omega-3 Lipid Emulsion Multicenter Trial |
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Reduction of length of postoperative hospital stay by fish oil
containing lipid emulsion – data from a multicenter trial
List of authors of this study
- Wichmann M.
Department of Surgery, Klinikum Großhadern, Ludwig-Maximilian Universität,
Munich, Germany
- Morlion B.
Department of Anaesthesiology, Multidisciplinary Pain Center, University
Hospital Leuven, Belgium
- Czarnetzki H.-D.
Department of Surgery, South Rostock Hospital, Germany
- Thul P.
Department of Surgery, Charité, Humboldt-University Berlin, Germany
- Jauch K.W.
Department of Surgery, Klinikum Großhadern, Ludwig-Maximilian Universität,
Munich, Germany
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Introduction
The postoperative course of patients after major abdominal surgery is
frequently characterized by inflammatory complications causing the
need for a multiplicity of additional care and a prolonged hospital
stay.
Omega-3 fatty acids (FA) have been reported to decrease interleukin-6
(IL-6) and to increase leukotriene B5 (LTB5, metabolic product from
eicosapentaenoic acid; EPA) concentration in patients after major abdominal
surgery suggesting an immune-modulating effect.
Omega-3 FA thus could alleviate
the consequences of systemic inflammatory responses. Provided as a
component of parenteral nutrition, Omega-3 FA were investigated for
their immuno modulatory effects, clinical safety and their effect on
length of postoperative hospital stay (LOS) in a large multicenter
clinical trial with patients after major abdominal surgery. |
Methods
Patients from four surgical units (n = 256) were randomized to postoperatively
receive a 5 day parenteral nutrition regimen containing a lipid emulsion
of either 50% Medium Chain Triglycerides; MCT, 40% Long Chain Triglycerides;
LCT and 10% Fish Oil; FO i.e. MLF 541 (Lipoplus®
group I, n = 127) or of 100% LCT (Intralipid® group II, n = 129).
Changes in polyunsaturated fatty acids (PUFA) content in plasma phospholipids
were measured and analyzed on day 1 and 5 of parenteral nutrition in
a subset of 2 × 16 patients.
LOS was calculated as time from surgery until hospital discharge.
Safety was assessed by documentation of postoperative complications
during the observational period. |
Results
Patients in either group did not differ significantly with regard to
age, sex, BMI (Body Mass Index) and incidence of carcinoma (tables
1 and 2). LOS for patients in group II was
21.9 days 95%-Confidence Intervalls; CI (19.5, 24.3), compared to 17.2
days 95%-CIs (14.8, 19.6) for patients in group I (p = 0.00607) (figure
1). Evaluation of Omega-6 PUFA (linoleic acid) concentration on
days 1 (d1) and 5 (d5) did not reveal group differences while Omega-3
PUFA-concentration (EPA) was significantly elevated in the MLF541 group
(table 3).
Postoperative complications assessed to obtain information about treatment
safety did reveal comparable results for both treatment groups (table
4). |
| Table 1. Demographic
characterization of patients randomized for participation in the study |
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MLF 541 |
LCT |
significance
of differences |
| Age / mean ± SD |
59.6 ± 11.63 |
59.1 ± 11.50 |
p = 0.651 |
Sex |
f
m |
n = 56
n = 71 |
n = 56
n = 73 |
p = 0.912 |
Weight
mean ± SD |
f
m |
67.0 ± 13.28
76.4 ± 11.32 |
65.3 ± 12.17
78.9 ± 11.94 |
p = 0.961
p = 0.591 |
BMI
mean ± SD |
f
m |
25.16 ± 4.74
24.91 ± 3.10 |
24.62 ± 3.86
26.09 ± 3.95 |
p = 0.591
p = 0.091 |
f = female
m = male |
1 Wilcoxon Mann Whitney,
2 Chi-Square |
| Table 2. Frequency of
carcinoma, difference between treatment groups is not significant (Chi-Square
p = 0.22) |
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| Treatment |
No Carcinoma n (%) |
Carcinoma n (%) |
| MLF 541 |
39 (30.7) |
88 (69.3) |
| LCT |
49 (38.0) |
80 (62.0) |
Total Number
of Patients n |
88 (34.38) |
168 (65.62) |
| Table 3. Changes in EPA and AA concentration of plasma phospholipids within and between groups. Enlarge
this table >> |
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| Figure 1. Length of postoperative hospital stay (LOS) under treatment with MLF541 and LCT |
| Table 4. Postoperative
complications |
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| Postoperative Complications |
MLF541 n
(%) |
LCT n
(%) |
p-value1 |
| Catheter Sepsis |
4 (3.1%) |
5 (3.9%) |
1.0000 |
| Tachycardia |
2 (1.6%) |
4 (3.1%) |
0.6838 |
| Arrhythmia |
1 (0.8%) |
0 (0.0%) |
0.4961 |
| Angina pectoris |
0 (0.0%) |
2 (1.6%) |
0.4981 |
| Pneumonia |
1 (0.8%) |
5 (3.9%) |
0.2133 |
| Fever/Temperature elevation |
5 (3.9%) |
8 (6.2%) |
0.5711 |
| 1 Significance of group differences
(Fisher exact two tailed) |
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Conclusion
Parenteral nutrition of patients after major abdominal surgery with a
nutrition regimen containing Omega-3 FA (MLF541) may cause a reduction
of length of hospital stay. As could be shown this effect is not due
to different characterization of the patient population, both groups
matched with regard to demographic characteristics and carcinoma frequency.
Instead further support for immuno modulatory features of Omega-3
FA was obtained. MLF541 has an Omega-3 to Omega-6 FA ratio of 1:3,
which leads to a shift in the balance between EPA and AA in the membrane
phospholipids towards EPA, without depleting AA. This may lead to a
more appropriate immune response through changes in the eicosanoids
produced and may be the origin of reduced postoperative length of hospital
stay by approximately 5 days.
Above results are in line with previous findings of IL6-lowering and
LTB5 increase under Omega-3 treatment. |
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