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Evaluation of efficacy, safety of SMOF 20% vs. Intralipid 20% during parenteral nutrition of moderate or major abdominal surgery: A prospective, controlled, randomised, double-blind, multicentre trial

Evaluation of efficacy, safety of SMOF 20% vs. Intralipid 20% during parenteral nutrition of moderate or major abdominal surgery: A prospective, controlled, randomised, double-blind, multicentre trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000230
Enrollment
Unknown
Registered
2008-12-14
Start date
2008-08-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate or major abdominal surgery.

Interventions

Experimental group:SMOFlipid 20%
Control group:SMOFlipid 20%

Sponsors

Nanjing General Hospital of Nanjing Military Command of Chinese PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Moderate or major abdominal surgery; patients to be treated with post-operative total parenteral nutrition over 5 days at least; 18-80 years old; patients has given his/her written informed consent.

Exclusion criteria

Exclusion criteria: Severe hyperlipidemia(plasma triglycerieds and/or cholesterol and/or LDL-C > 50% above the upper limit of normal range); type 1 diabetes mellitus and/or severe type 2 diabetes mellitus;metabolic diseases (hyperthyroidism/hypothyroidism, adrenal cortex disorders); BMI30 {BMI=Weight (Kg)/[Height (m) x height (m)]}; severe renal insufficiency(creatinine more than 200% above the upper limit of the normal ranges); severe liver insufficiency (AST and/or ALT and/or bilirubin more than 200% above the upper limit of the normal ranges);severe blood coagulation disorders; any condition of decompensated acute or chronic heart insufficiency;severe diseases or unstable vital signs within last 48 hours; history of organ transplantation;history of drug allergy, asthma, urticaria or known allergy to fish protein, egg protein or soy protein;concomitant other nutrition therapy or medications may influence nutrition therapy (e.g. somatotropin); pregnancy or breast-feeding women; participation in other clinical trials within 4 weeks prior to the beginning of this study.

Design outcomes

Primary

MeasureTime frame
concentration of triglycerides, prealbumin, transf;

Secondary

MeasureTime frame
The serum levels of total cholesterol, total prote;Blood free fatty acid spectrum;LTB5 / LTB4, TXB3 / TXB2 ratio;IL-1, IL-2, IL-6 and CD4 / CD8 and HLA-DR level;

Countries

China

Contacts

Public ContactLi Ning
liningrigs@vip.sina.com+86 0 13821595388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026