Parenteral NutritionPhase 4NCT07878468
Effects of Preoperative Parenteral Nutrition With Omega-3 Fish Oil Lipid Emulsion on Postoperative Outcomes in Patients Undergoing Major Abdominal Surgery
A Phase 4 study testing ω-3 fish oil lipid emulsion and Conventional lipid without ω-3 fish oil in people with Parenteral Nutrition and Nutritional Status, run by Second Affiliated Hospital of Nanchang University at 7 sites in China.
Trial summary
The goal of this study is to explore if preoperative ω-3 fish oil lipid emulsion parenteral nutrition (PN) can improve postoperative outcomes in patients undergoing major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parenteral Nutrition, Nutritional Status, Major Abdominal Surgery
- What is being tested?
- ω-3 fish oil lipid emulsion and Conventional lipid without ω-3 fish oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 7 sitesChina
- Study dates
- Oct 2026to Jan 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 80 years old;
- NRS2002 score ≥ 3 points;
- Diagnosed as malnourished or at high risk of malnutrition according to the GLIM standard;
- Patients undergoing elective major abdominal surgery with an estimated operation time of ≤ 4 hours;
- Voluntary participants in this clinical study, with patients or their families signing the informed consent form.
Who cannot join
- Patients with severe hyperlipidemia (such as hypertriglyceridemia), severe coagulation disorders or acute thrombo/thrombotic diseases (including fat embolism), intrahepatic cholestasis, liver failure, renal failure that cannot undergo hemofiltration/dialysis, acute myocardial infarction or stroke;
- Patients with moderate/severe diseases (sepsis, mechanical intestinal obstruction);
- Have the following contraindications for intravenous infusion: hemodynamic instability (such as collapse or shock), metabolic disorders (severe trauma, severe sepsis, acidosis), insufficient cellular oxygen supply, acute pulmonary edema, compensatory heart failure, or electrolyte imbalance (water intoxication, hypotonic dehydration, hypokalemia);
- Pregnant or lactating;
- Have immune system diseases or are undergoing immunomodulatory therapy or have undergone splenectomy;
- Use glucocorticoid anti-inflammatory drugs, thyroid drugs;
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- Allergic to ω-3 fat emulsions or allergic to other drug components used in the study (such as eggs, fish, soy protein, peanut protein or other components in the prescription);
- Have mental disorders or are unable to cooperate with treatment and follow-up;
- Participate in other clinical trials;
- The investigator deems it inappropriate for the patient to participate in this study for other reasons.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
The People's Hospital of Dexing
Dexing, Jiangxi, 334200
Xigao Ye, 86-0793-7973711, 53118541@qq.com
Ganzhou People's Hospital
Ganzhou, 341000
Chuanfa Fang, 86-0797-5889720, Fangcf6113872@163.com
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jiaqing Cao, 86-13907008850, cao.jiaqing@163.com
The First Hospital of Nanchang
Nanchang, Jiangxi, 330008
Peng Deng, 86-0791-88862256, jxncxjxdp@163.com
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Haiyun Wei, 86-0791-88317256, whyjxth@163.com
The People's Hospital of Wanzai County
Wanzai, Jiangxi, 336100
Jianguo Deng, 86-0795-8981429, wy8981429@sina.com
Yichun People's Hospital
Yichun, Jiangxi, 336000
Jun Hu, 86-0795-3236541, hujungoing@163.com
About this study
Official title: Effects of Preoperative Parenteral Nutrition With Omega-3 Fish Oil Lipid Emulsion on Postoperative Outcomes in Patients Undergoing Major Abdominal Surgery: A Prospective, Multicenter, Real-World Study
The goal of this study is to explore if preoperative ω-3 fish oil lipid emulsion parenteral nutrition (PN) can improve postoperative outcomes in patients undergoing major abdominal surgery. The main questions it aims to answer are:
- Does preoperative PN containing ω-3 fish oil lipid emulsion improve postoperative nutritional status (prealbumin, albumin) in patients undergoing major abdominal surgery?
- Does preoperative PN containing ω-3 fish oil lipid emulsion affect other postoperative clinical outcomes (length of hospital stay, inflammatory status, postoperative complication rates, BMI changes, liver function changes, time to first flatus and defecation) in these patients? Researchers will compare the ω-3 fish oil lipid emulsion PN group (preoperative ω-3 PN) to the control group (preoperative normal diet) to see if there are differences in postoperative nutritional status, safety, and other clinical outcomes.
Read more
Participants will:
- In the intervention group, receive preoperative parenteral nutrition containing ω-3 fish oil lipid emulsion.
- In the control group, maintain a normal preoperative diet.
- Undergo blood tests and clinical assessments at baseline (before PN use) and on postoperative days 1, 3, and 7 (or at discharge, whichever comes first).
- Being tested
- ω-3 fish oil lipid emulsion, Conventional lipid without ω-3 fish oil
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ω-3 fish oil lipid emulsionDrug
In the ω-3 group, receive preoperative parenteral nutrition containing ω-3 fish oil lipid emulsion.
Conventional lipid without ω-3 fish oilDrug
Receiving parenteral nutrition without fish oil fat emulsion with equal nitrogen and heat content
| Study group | Role | What they receive |
|---|---|---|
| ω-3 group | Experimental | Two days before the scheduled surgery, while maintaining a normal diet, an intravenous infusion of parenteral nutrition solution prepared from ω-3 fish oil and medium/long chain fat emulsion was administered daily. Receives: Drug: ω-3 fish oil lipid emulsion |
| Conventional lipid group | Active comparator | Receiving parenteral nutrition without fish oil fat emulsion with equal nitrogen and heat content Receives: Drug: Conventional lipid without ω-3 fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum albumin and prealbumin levels
Levels of serum albumin and prealbumin will be measured at baseline (preoperative Day 1) and postoperatively on Days 1, 3, and 7. If discharged before Day 7, the final measurement will be taken on the day of discharge.
Measured: Preoperative Day 1, and postoperative Days 1, 3, and 7
Length of hospital stay (days)
Length of hospital stay will be calculated as the number of days from surgery to discharge. If a patient is still hospitalized at the end of the study period, the outcome will be censored at 30 days.
Measured: From surgery to hospital discharge (up to 30 days)
Secondary outcomes (4)
White blood cell count, lymphocyte count, and C-reactive protein (CRP) levels
Levels of white blood cells (WBC), lymphocytes, and C-reactive protein (CRP) will be measured from blood samples at baseline (preoperative Day 1) and postoperatively on Days 1, 3, and 7.
Measured: Baseline (Day -1), and postoperative Days 1, 3, and 7
Incidence of postoperative complications (hypoproteinemia, anastomotic leakage, ileus, postoperative hemorrhage, renal failure, and thromboembolic events)
Postoperative complications will be monitored and recorded from the end of surgery until hospital discharge, with a maximum follow-up of 30 days after surgery. The complications assessed include hypoproteinemia, anastomotic leakage, ileus, postoperative hemorrhage, renal failure, and thromboembolic events.
Measured: From surgery to hospital discharge (up to 30 days post-surgery)
Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels
Serum levels of total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) will be measured from blood samples at baseline (preoperative Day 1) and postoperatively on Days 1, 3, and 7.
Measured: Baseline (Day -1), and postoperative Days 1, 3, and 7
Time to first flatus and defecation
Time to first flatus and time to first defecation will be defined as the interval (in hours or days) from the end of surgery to the first postoperative passage of flatus or defecation, respectively. Patients will be followed daily during hospitalization.
Measured: From the end of surgery up to postoperative Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaqing Cao, Second Affiliated Hospital of Nanchang University
- Investigators
- Jiaqing Cao, Principal investigator, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878468
- Sponsor's protocol ID
- IIT-2026-167
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the article is published, de-identified data can be obtained from corresponding author upon reasonable request.