Effect of Alpha-lipoic Acid on Biochemical Markers and Important Outcomes in Patients Admitted to Intensive Care Units

Overview

Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. In this double blind clinical trial, the investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive care unit that the investigators expect to stay for more than 7 days in this ward and who have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After randomization of included patients by block randomization the investigators will give 900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency period, length of stay in ICU, mortality and decelerate of organ failures.

Full Title of Study: “Evaluating the Effect of Alpha Lipoic Acid on Biochemical Markers, Length of Stay and Other Important Outcomes in Patients Admitted to Intensive Care Units.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: September 2013

Interventions

  • Dietary Supplement: alpha-lipoic acid
    • the patients in this arm receive 900mg alpha-lipoic acid through NG tube.
  • Drug: placebo
    • the patients in this arm were received 900mg placebo through NG tube.

Arms, Groups and Cohorts

  • Experimental: alpha-lipoic acid
    • the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube.
  • Placebo Comparator: placebo
    • the patients in this arm were received 900mg placebo through NG tube.

Clinical Trial Outcome Measures

Primary Measures

  • length of stay in ICU
    • Time Frame: day 28
    • number of days that patient stay in intensive care unit
  • mortality
    • Time Frame: day 28
    • percent of mortality
  • ventilator free days
    • Time Frame: 10 days
    • show by days

Secondary Measures

  • sequential organ failure assessment score
    • Time Frame: 10 days
    • determine by SOFA score form
  • insulin resistance
    • Time Frame: 10 days
    • measure by HOMA calculation equation
  • malondialdehyde
    • Time Frame: 10 days
    • measure by spectrophotometery
  • total antioxidant capacity
    • Time Frame: 10 days
    • measure by eliza kit
  • C reactive protein
    • Time Frame: 10 days
    • measure by nephelometry method
  • interleukin-6
    • Time Frame: 10 days
    • measure by eliza kit
  • Albumin
    • Time Frame: 10 days
    • record from routine lab data of patients in hospital
  • preAlbumin
    • Time Frame: 10 days
    • by turbidimetric assay
  • Total lymphocyte count
    • Time Frame: 10 days
    • record from routine lab data of patients in hospital
  • Mid arm circumference
    • Time Frame: 10 days
    • measure by non flexible meter in mid arm
  • total protein
    • Time Frame: 10 days
    • record from routine lab data of patients in hospital

Participating in This Clinical Trial

Inclusion Criteria

  • age ≥ 18; – expected length of stay more than 7 days; – using enteral feeding method during admitted to ICU Exclusion Criteria:

  • having the history of autoimmune disease – severe renal or liver failure – AIDS, – hepatitis; – having severe malnutrition at the admission time; – having TPN at the admission time in ICU; – extreme intolerance to enteral feeding.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • najmeh hejazi
  • Collaborator
    • Shiraz University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: najmeh hejazi, PhD of Nutrition,Shiraz University of Medical Sciences – Shiraz University of Medical Sciences
  • Overall Official(s)
    • Najmeh Hejazi, Ph.D, Principal Investigator, Shiraz University of Medical Sciences,Nutrition department
    • Zohreh Mazloom, PhD, Study Director, Shiraz University of Medical Sciences, Faculty of Nutrition
    • Farid Zand, MD, Study Chair, Shiraz University of Medical Sciences, anesthesiology and critical care research center
  • Overall Contact(s)
    • Najmeh Hejazi, Ph.D, n20hejazi@yahoo.com

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