Format

Send to

Choose Destination
Nutr J. 2015 Nov 14;14:119. doi: 10.1186/s12937-015-0100-6.

Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China.

Author information

1
Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. jzhyjia@163.com.
2
Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. yanjuns@foxmail.com.
3
Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. xiayang73@163.com.
4
Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. danian78@163.com.
5
Baxter Healthcare, Deerfield, IL, 60015, USA. gary_zaloga@baxter.com.
6
Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. hlqin1965@163.com.
7
General Surgery, Shanghai Tenth People's Hospital (Tenth People'sHospital of Tongii University), Shanghai, 200072, China. hlqin1965@163.com.

Abstract

BACKGROUND:

Small studies suggest differences in efficacy and safety exist between olive oil-based (OLIVE) and soybean oil-based (SOYBEAN) parenteral nutrition regimens in hospitalized adult patients. This large, prospective, randomized (1:1), open-label, multi-center, noninferiority study compared the delivery, efficacy, and safety of OLIVE (N = 226) with SOYBEAN (N = 232) in Chinese adults (≥18 years) admitted to a surgical service for whom parenteral nutrition was required.

METHODS:

Treatments were administered for a minimum of 5 days up to 14 days (to achieve approximately 25 kcal/kg/day, 0.9 g/kg/day amino acids, 0.8 g/kg/day lipid). Impact of treatment on anabolic/catabolic and serum inflammatory, chemistry, and hematological markers, safety, and ease of use were assessed. The primary efficacy variable was serum prealbumin level at Day 5.

RESULTS:

OLIVE (n = 219) was not inferior to SOYBEAN (n = 224) based on the prealbumin least square geometric mean [LSGM] ratio [95% CI] 1.12 [1.06, 1.19]; P = 0.002), improved the anabolic/catabolic status of patients enrolled in the study, and was well tolerated compared with SOYBEAN. Improved anabolic status was supported by significantly higher levels of prealbumin at Day 5, albumin at Day 5 and IGF-1 at Day 14 in the OLIVE group, while catabolism was similar between groups. C-reactive protein, intercellular adhesion molecule-1, procalcitonin, and oxidation were similar in each group, but infections were significantly lower with OLIVE (3.6% versus 10.4%; P < 0.01).

CONCLUSIONS:

OLIVE provided effective nutrition, was well tolerated, was associated with fewer infections, and conferred greater ease-of-use than SOYBEAN.

TRIAL REGISTRATION:

NTC 01579097.

PMID:
26574019
PMCID:
PMC4647821
DOI:
10.1186/s12937-015-0100-6
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center