Clinical Trial: THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.

Brief Summary: The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. All the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after infusion.

Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India

Current Primary Outcome:

  • Effect of intravenous lipid on monocytes counts. [ Time Frame: 3 days ]
  • Effect of intravenous lipid on neutrophils counts. [ Time Frame: 3 days ]
  • Effect of intravenous lipid on macrophages count. [ Time Frame: 3 days ]


Original Primary Outcome:

  • Effect of intravenous lipid on monocytes counts. [ Time Frame: 3 days ]
  • Effect of intravenous lipid on netrophils counts. [ Time Frame: 3 days ]
  • Effect of intravenous lipid on macrophages count. [ Time Frame: 3 days ]


Current Secondary Outcome:

  • Influence of lipid infusion on TEG (Thromboelastography) [ Time Frame: 3 days ]
  • Influence of lipid infusion on TNF-α (Tumor Necrosis Factor). [ Time Frame: 3 days ]
  • Influence of lipid infusion on interleukin levels (IL-6, IL-10). [ Time Frame: 3 days ]
  • Influence of lipid infusion on PT/INR [ Time Frame: 3 days ]
  • Influence of lipid infusion on PTT. [ Time Frame: 3 days ]
  • Influence of lipid infusion on liver parameters. [ Time Frame: 3 days ]
  • Influence of lipid infusion on arterial ammonia. [ Time Frame: 3 days ]
  • Influence of lipid infusion on renal parameters. [ Time Frame: 3 days ]


Original Secondary Outcome:

  • Influence of lipid infusion on TEG (Thromboelastography) [ Time Frame: 3 days ]
  • Influence of lipid infusion on TNF-α (Tumor Necrosis Factor). [ Time Frame: 3 days ]
  • Influence of lipid infusion on interleukin levels (IL-6, IL-10). [ Time Frame: 3 days ]
  • Influence of lipid infusion on PT/INR [ Time Frame: 3 days ]
  • Influence of lipid infusion on PTT. [ Time Frame: 3 days ]
  • Influence of lipid infusion on sonoclot. [ Time Frame: 3 days ]
  • Influence of lipid infusion on liver parameters. [ Time Frame: 3 days ]
  • Influence of lipid infusion on arterial ammonia. [ Time Frame: 3 days ]


Information By: Institute of Liver and Biliary Sciences, India

Dates:
Date Received: February 23, 2015
Date Started: June 2013
Date Completion:
Last Updated: September 9, 2016
Last Verified: December 2014