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

NCT ID: NCT01888861

Last Updated: 2013-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Oxidative Stress Inflammation Malnutrition

Keywords

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length of stay in ICU ventilator free days

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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alpha-lipoic acid

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

Group Type EXPERIMENTAL

alpha-lipoic acid

Intervention Type DIETARY_SUPPLEMENT

the patients in this arm receive 900mg alpha-lipoic acid through NG tube.

placebo

the patients in this arm were received 900mg placebo through NG tube.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

the patients in this arm were received 900mg placebo through NG tube.

Interventions

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alpha-lipoic acid

the patients in this arm receive 900mg alpha-lipoic acid through NG tube.

Intervention Type DIETARY_SUPPLEMENT

placebo

the patients in this arm were received 900mg placebo through NG tube.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role collaborator

najmeh hejazi

OTHER

Sponsor Role lead

Responsible Party

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najmeh hejazi

PhD of Nutrition,Shiraz University of Medical Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Najmeh Hejazi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences,Nutrition department

Zohreh Mazloom, PhD

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences, Faculty of Nutrition

Farid Zand, MD

Role: STUDY_CHAIR

Shiraz University of Medical Sciences, anesthesiology and critical care research center

Locations

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Shiraz University of Medical Sciences, Department of Nutrition

Shiraz, Fars, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Najmeh Hejazi, Ph.D

Role: CONTACT

Email: [email protected]

Facility Contacts

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Najmeh Hejazi, PhD

Role: primary

Other Identifiers

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916423

Identifier Type: -

Identifier Source: org_study_id