Application of n-3 Fatty to Patient of Jaundice

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03376945

Collaborator

(none)

106

Enrollment

Location

45.4

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Jaundice Surgical Procedure, Unspecified	Drug: trail cohort Drug: control cohort

Detailed Description

Lipid emulsion enriched in n-3 fatty acid (FA) has been reported to improve postoperative recovery for surgical patients with biliary tract disease, and to improve laboratory and clinical outcomes. The role of it for postoperative patients with jaundice is not clear yet. The object of this research was to evaluate the safety and efficacy of n-3 fatty acid-based parenteral nutrition (PN) for patients with jaundice following Surgical procedure.

This cohort study was a pragmatic, retrospective, single center, matched, clinical trial from May 2014 to June 2017.

Study Design

Study Type:

Observational

Actual Enrollment :

106 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Safety and Efficacy of n-3 Fatty Acid-based Parenteral Nutrition in Patients With Obstructive Jaundice: A Propensity-matched Study

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
trail cohort n-3 FAs	Drug: trail cohort 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. Other Names: trail
control cohort Structolipid	Drug: control cohort 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. Other Names: control

Arm

Intervention/Treatment

trail cohort

n-3 FAs

Drug: trail cohort

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.

Other Names:

trail

control cohort

Structolipid

Drug: control cohort

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.

Other Names:

control

Outcome Measures

Primary Outcome Measures

Safety (complications) [postoperative period（1 month ）]
postoperative complications
velocity of the serum total bilirubin clearance [postoperative period（1 month ）]
the velocity of the serum TBIL clearance, which was calculated according to formula behind: (formal TB -TB of current) /time interval

Secondary Outcome Measures

kidney function [postoperative period（1 month ）]
blood test for GFR and creatinine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.