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

N

najmeh hejazi

Status and phase

Unknown
Phase 3

Conditions

Inflammation
Malnutrition
Oxidative Stress

Treatments

Drug: placebo
Dietary Supplement: alpha-lipoic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01888861
916423

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Central trial contact

Najmeh Hejazi, Ph.D

Data sourced from clinicaltrials.gov

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