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

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ClinicalTrials.gov Identifier: NCT01888861
Recruitment Status : Unknown
Verified June 2013 by najmeh hejazi, Shiraz University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
najmeh hejazi, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Inflammation Malnutrition Dietary Supplement: alpha-lipoic acid Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : February 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. length of stay in ICU [ Time Frame: day 28 ]
    number of days that patient stay in intensive care unit

  2. mortality [ Time Frame: day 28 ]
    percent of mortality

  3. ventilator free days [ Time Frame: 10 days ]
    show by days


Secondary Outcome Measures :
  1. sequential organ failure assessment score [ Time Frame: 10 days ]
    determine by SOFA score form

  2. insulin resistance [ Time Frame: 10 days ]
    measure by HOMA calculation equation

  3. malondialdehyde [ Time Frame: 10 days ]
    measure by spectrophotometery

  4. total antioxidant capacity [ Time Frame: 10 days ]
    measure by eliza kit

  5. C reactive protein [ Time Frame: 10 days ]
    measure by nephelometry method

  6. interleukin-6 [ Time Frame: 10 days ]
    measure by eliza kit

  7. Albumin [ Time Frame: 10 days ]
    record from routine lab data of patients in hospital

  8. preAlbumin [ Time Frame: 10 days ]
    by turbidimetric assay

  9. Total lymphocyte count [ Time Frame: 10 days ]
    record from routine lab data of patients in hospital

  10. Mid arm circumference [ Time Frame: 10 days ]
    measure by non flexible meter in mid arm

  11. total protein [ Time Frame: 10 days ]
    record from routine lab data of patients in hospital



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888861


Contacts
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Contact: Najmeh Hejazi, Ph.D n20hejazi@yahoo.com

Locations
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Iran, Islamic Republic of
Shiraz University of Medical Sciences, Department of Nutrition Recruiting
Shiraz, Fars, Iran, Islamic Republic of, 7157617516
Contact: Najmeh Hejazi, PhD       n20hejazi@yahoo.com   
Principal Investigator: Najmeh Hejazi, PhD         
Sponsors and Collaborators
najmeh hejazi
Shiraz University of Medical Sciences
Investigators
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Principal Investigator: Najmeh Hejazi, Ph.D Shiraz University of Medical Sciences,Nutrition department
Study Director: Zohreh Mazloom, PhD Shiraz University of Medical Sciences, Faculty of Nutrition
Study Chair: Farid Zand, MD Shiraz University of Medical Sciences, anesthesiology and critical care research center
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Responsible Party: najmeh hejazi, PhD of Nutrition,Shiraz University of Medical Sciences, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01888861    
Other Study ID Numbers: 916423
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013
Keywords provided by najmeh hejazi, Shiraz University of Medical Sciences:
length of stay in ICU
ventilator free days
Additional relevant MeSH terms:
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Malnutrition
Inflammation
Pathologic Processes
Nutrition Disorders
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances