A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Summary

Here, we present a protocol for a study comparing the efficacy, safety, and delivery of olive-oil-based 3CB and soybean-oil-based CoB formulations in adults requiring parenteral nutrition. The results revealed that olive-oil-based 3CBs is non-inferior and well tolerated compared to soybean formulations.

Abstract

Limited evidence exists to precisely estimate efficacy and safety differences between parenteral nutrition (PN) prepared using olive-oil-based three-chamber bags (3CBs) and soybean-oil-based compounded bags (CoBs) in hospitalized adult patients. We designed a multicenter, randomized, prospective, open-label, noninferiority protocol to compare the efficacy, safety, and distribution of olive-oil-based 3CBs and soybean-oil-based CoB formulations in adult Chinese patients requiring PN during surgical intervention. Subjects were randomized to receive either one of the study treatments using an interactive voice or web-based recognition system in accordance with the randomization code. Randomization was further stratified based on the study site and surgical category. Both treatment groups received similar amounts of calories and protein. In addition, the two study treatments contained a similar composition of the amino-acid component. The only difference between the two PN formulations was the lipid constitution. The duration of administration of study treatments was a minimum of 5 days up to a maximum of 14 days after the surgical procedure. The primary efficacy endpoint was serum prealbumin levels on day 5 of the study. Noninferiority was proved if the anti-log of the lower bound of the 95% confidence interval (CI) of the treatment difference was at least 0.80. Other efficacy measures included treatment preparation time; duration to achieve tolerability of oral nutrition; associated infectious complications; length of hospitalization; and laboratory assessment of markers of nutrition, inflammation, metabolism, and oxidative stress. A total of 458 patients were enrolled in the study. The results showed that olive-oil-based 3CBs were non-inferior to soybean-based CoBs, besides being well tolerated. The infection rate was found to be significantly lower in the olive-oil-based 3CB group. Thus, this study may be used as a reference for future research on lipid emulsion and 3CBs.

Introduction

Parenteral nutrition is an essential component of overall therapy for a wide spectrum of indications, such as major gastrointestinal surgery, transient enteral intolerance, severe burns, coma; or for use in critically ill patients. Improvements in intravenous (IV) nutritional formulations and knowledge advancement regarding the implementation of therapy allow the safe and clinically efficacious administration of IV nutrition. These characteristics are particularly important in a metabolically stressed patient¹.

Parenteral nutrition is commonly administered to patients by mixing nutrients that are compounded in the ho....

Protocol

For this prospective, randomized, multicenter, active-controlled, parallel-group investigational trial, the Ethics Committees of Shanghai Sixth People’s Hospital approved the study protocol.

1. Patient recruitment and enrollment

1. Recruit patients as per the inclusion criteria specified in the protocol. Seek informed consent from patients and perform screening assessments not more than 3 days prior to the scheduled surgery.
2. Randomize enrolled subjects to one of the two study treatments (olive-oil-based 3CBsor soybean-oil-based CoBs), based on the randomization schedule.
   1. Randomize subjects undergoing sur....

Results

Patient Disposition
Out of the 480 patients who gave their consent, a total of 458 patients were enrolled and randomized in the study. The ITT population included all randomized patients, of whom 226 constituted the test group and 232 the control group. The safety population included a total of 453 patients, of whom 222 belonged to the test group and 231 to the control group. The modified intention-to-treat (mITT) population comprised a total of 443 patients, of whom 219 were in the test group and 22.......

Discussion

The randomized clinical trial protocol is a multi-purpose document. It not only provides guidance for the conduct of trial to the investigators, but it also makes ethics committees and institutional review boards aware of appropriate measures adopted to protect participants’ safety and interests. A proper design is crucial for the success of a clinical trial. It is often noted that the design of a trial is connected with its successes/failures⁸.

Additionally, sele.......