Clinical trial NCT01888861: Effect of Alpha-lipoic Acid on Biochemical Markers and Important Outcomes in Patients Admitted to Intensive Care Units
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oxidative Stress
Inflammation
Malnutrition
Keywords: length of stay in ICU
ventilator free days
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shiraz University of Medical Sciences
First posted: 2013-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: length of stay in ICU
timeFrame: day 28
measure: mortality
timeFrame: day 28
measure: ventilator free days
timeFrame: 10 days
Secondary outcomes:
measure: sequential organ failure assessment score
timeFrame: 10 days
measure: insulin resistance
timeFrame: 10 days
measure: malondialdehyde
timeFrame: 10 days
measure: total antioxidant capacity
timeFrame: 10 days
measure: C reactive protein
timeFrame: 10 days
measure: interleukin-6
timeFrame: 10 days
measure: Albumin
timeFrame: 10 days
measure: preAlbumin
timeFrame: 10 days
measure: Total lymphocyte count
timeFrame: 10 days
measure: Mid arm circumference
timeFrame: 10 days
measure: total protein
timeFrame: 10 days
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences, Department of Nutrition
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences,Nutrition department
name: Najmeh Hejazi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences, Faculty of Nutrition
name: Zohreh Mazloom, PhD
role: STUDY_DIRECTOR
affiliation: Shiraz University of Medical Sciences, anesthesiology and critical care research center
name: Farid Zand, MD
role: STUDY_CHAIR
References: