Application of n-3 Fatty to Patient of Jaundice

NCT03376945 | Completed DMC

• 1 other identifier: Chenxp009
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The safety and efficacy of ω-3 fatty acid in patients with obstructive jaundice is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for patients with obstructive jaundice.

Conditions

Obstructive Jaundice; Surgical Procedure, Unspecified

Keywords

n-3; Parenteral nutrition; Jaundice; Propensity score match

Outcome Measures

Primary Outcomes (2)

• Safety (complications)

  postoperative complications

  postoperative period（1 month ）

• velocity of the serum total bilirubin clearance

  the velocity of the serum TBIL clearance, which was calculated according to formula behind: (formal TB -TB of current) /time interval

  postoperative period（1 month ）

Secondary Outcomes (1)

• kidney function

  postoperative period（1 month ）

Study Arms (2)

trail cohort

n-3 FAs

Drug: trail cohort

control cohort

Structolipid

Drug: control cohort

Interventions

trail cohort DRUG

Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 fatty acid \[FA\] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.

Also known as: trail

trail cohort

control cohort DRUG

Drug: Structolipid Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.

Also known as: control

control cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This cohort study was a pragmatic, retrospective, single center, matched, clinical trial from May 2014 to June 2017.The trail included obstructive jaundice patients ≥20 years who received PN treatment for ≥5 days for maintenance and improvement of their nutrition status round the operation period. All patients received PN along with the three macronutrients, compounded in an "All-In-One" manner, included amino acids, lipids and glucose, electrolytes, and micronutrients (trace elements and vitamins). The administration was performed with a perfusion pump through a central line within 24 h.

You may qualify if:

• the diagnosis of obstructive jaundice must be clear (serum toal bilirubin \>51.3umol/L \& Imaging evidence), and the obstruction is located in the extrahepatic bile duct;
• Duration of Jaundice is less than 2 weeks;
• Nutritional support is needed
• Nutritional support was administrated during the perioperative period;
• Drainage treatment is effective.

You may not qualify if:

• Contraindication for surgical procedure, including Child-Pugh Classification C, severe hemorrhagic disorders, gastrointestinal hemorrhage, acute infectious disease, active phase of chronic hepatitis B \& C, severe circulatory disease, renal failure pre -operation, and other unknown cause;
• Abandon treatment;
• Length of stay in hospital \<5 day;
• Nutrition support \<5 day;
• Conservative treatment;
• Incomplete data;
• Allergic reactions against PN.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Hepatic Surgery Center of Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Gong Q, Zhu P, Zhang B, Shu C, Ding Z, Wu J, Zhang B, Chen XP. Safety and efficacy of n-3 fatty acid-based parenteral nutrition in patients with obstructive jaundice: a propensity-matched study. Eur J Clin Nutr. 2018 Aug;72(8):1159-1166. doi: 10.1038/s41430-018-0256-1. Epub 2018 Jul 13.

  PMID: 30006616 DERIVED

MeSH Terms

Conditions

Jaundice, Obstructive; Hyperphagia; Jaundice

Interventions

TNF-Related Apoptosis-Inducing Ligand

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Tumor Necrosis Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Xiaoping Chen, Doctor

  Huazhong University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 19, 2017
• Study Start: January 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 15, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

CN (1)