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

Phase 3

• Conditions: Oxidative Stress; Inflammation; Malnutrition
• Interventions: Drug: placebo; Dietary Supplement: alpha-lipoic acid

• Registration Number: NCT01888861
• Lead Sponsor: najmeh hejazi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-06
• Study First Submitted: 2013-06-23
• Study First Submitted QC: 2013-06-27
• Last Update Submitted: 2013-06-27
• Study First Posted: 2013-06-28
• Last Update Posted: 2013-06-28
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	the patients in this arm were received 900mg placebo through NG tube.
alpha-lipoic acid	alpha-lipoic acid	the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shiraz University of Medical Sciences, Department of Nutrition; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of