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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01888861
• Other study ID #: 916423
• Status: Recruiting
• Phase: Phase 3
• First received: June 23, 2013
• Last updated: June 27, 2013
• Start date: February 2013
• Est. completion date: September 2013

Study information

• Verified date: June 2013
• Source: Shiraz University of Medical Sciences
• Contact: Najmeh Hejazi, Ph.D
• Email: n20hejazi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Malnutrition
• Oxidative Stress

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences, Department of Nutrition	Shiraz	Fars

Sponsors (2)

Lead Sponsor	Collaborator
najmeh hejazi	Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay in ICU	number of days that patient stay in intensive care unit	day 28	No
Primary	mortality	percent of mortality	day 28	No
Primary	ventilator free days	show by days	10 days	No
Secondary	sequential organ failure assessment score	determine by SOFA score form	10 days	No
Secondary	insulin resistance	measure by HOMA calculation equation	10 days	No
Secondary	malondialdehyde	measure by spectrophotometery	10 days	No
Secondary	total antioxidant capacity	measure by eliza kit	10 days	No
Secondary	C reactive protein	measure by nephelometry method	10 days	No
Secondary	interleukin-6	measure by eliza kit	10 days	No
Secondary	Albumin	record from routine lab data of patients in hospital	10 days	No
Secondary	preAlbumin	by turbidimetric assay	10 days	No
Secondary	Total lymphocyte count	record from routine lab data of patients in hospital	10 days	No
Secondary	Mid arm circumference	measure by non flexible meter in mid arm	10 days	No
Secondary	total protein	record from routine lab data of patients in hospital	10 days	No