NCT01888861

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

June 23, 2013

Last Update Submit

June 27, 2013

Conditions

Oxidative StressInflammationMalnutrition

Keywords

length of stay in ICUventilator free days

Outcome Measures

Primary Outcomes (3)

  • length of stay in ICU

    number of days that patient stay in intensive care unit

    day 28

  • mortality

    percent of mortality

    day 28

  • ventilator free days

    show by days

    10 days

Secondary Outcomes (11)

  • sequential organ failure assessment score

    10 days

  • insulin resistance

    10 days

  • malondialdehyde

    10 days

  • total antioxidant capacity

    10 days

  • C reactive protein

    10 days

  • +6 more secondary outcomes

Study Arms (2)

alpha-lipoic acid

EXPERIMENTAL

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

Dietary Supplement: alpha-lipoic acid

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

alpha-lipoic acidDIETARY_SUPPLEMENT

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

alpha-lipoic acid
placeboDRUG

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

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18;
  • expected length of stay more than 7 days;
  • using enteral feeding method during admitted to ICU

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences, Department of Nutrition

Shiraz, Fars, 7157617516, Iran

RECRUITING

MeSH Terms

Conditions

InflammationMalnutrition

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Najmeh Hejazi, Ph.D

    Shiraz University of Medical Sciences,Nutrition department

    PRINCIPAL INVESTIGATOR

  • Zohreh Mazloom, PhD

    Shiraz University of Medical Sciences, Faculty of Nutrition

    STUDY DIRECTOR

  • Farid Zand, MD

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

    STUDY CHAIR

Central Study Contacts

Najmeh Hejazi, Ph.D

CONTACT

n20hejazi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD of Nutrition,Shiraz University of Medical Sciences

Study Record Dates

First Submitted

June 23, 2013

First Posted

June 28, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations

IR(1)