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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Malnutrition; Oxidative Stress
• Intervention / Treatment: Dietary supplement: alpha-lipoic acid; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Najmeh Hejazi, Ph.D; Email: n20hejazi@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of, 7157617516
      • Recruiting
      • Shiraz University of Medical Sciences, Department of Nutrition
      • Contact: Najmeh Hejazi, PhD; Email: n20hejazi@yahoo.com
      • Principal Investigator: Najmeh Hejazi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: alpha-lipoic acid; the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube.	Dietary supplement: alpha-lipoic acid; the patients in this arm receive 900mg alpha-lipoic acid through NG tube.
Placebo Comparator: placebo; the patients in this arm were received 900mg placebo through NG tube.	Drug: placebo; the patients in this arm were received 900mg placebo through NG tube.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: najmeh hejazi
• Collaborators: Shiraz University of Medical Sciences
• Investigators: Study Director: Zohreh Mazloom, PhD, Shiraz University of Medical Sciences, Faculty of Nutrition; Principal Investigator: Najmeh Hejazi, Ph.D, Shiraz University of Medical Sciences,Nutrition department; Study Chair: Farid Zand, MD, Shiraz University of Medical Sciences, anesthesiology and critical care research center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: June 23, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: length of stay in ICU; ventilator free days
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Inflammation; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: 916423