search
Back to results

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

Primary Purpose

Oxidative Stress, Inflammation, Malnutrition

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
alpha-lipoic acid
placebo
Sponsored by
najmeh hejazi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxidative Stress focused on measuring length of stay in ICU, ventilator free days

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shiraz University of Medical Sciences, Department of NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

alpha-lipoic acid

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

length of stay in ICU
number of days that patient stay in intensive care unit
mortality
percent of mortality
ventilator free days
show by days

Secondary Outcome Measures

sequential organ failure assessment score
determine by SOFA score form
insulin resistance
measure by HOMA calculation equation
malondialdehyde
measure by spectrophotometery
total antioxidant capacity
measure by eliza kit
C reactive protein
measure by nephelometry method
interleukin-6
measure by eliza kit
Albumin
record from routine lab data of patients in hospital
preAlbumin
by turbidimetric assay
Total lymphocyte count
record from routine lab data of patients in hospital
Mid arm circumference
measure by non flexible meter in mid arm
total protein
record from routine lab data of patients in hospital

Full Information

First Posted
June 23, 2013
Last Updated
June 27, 2013
Sponsor
najmeh hejazi
Collaborators
Shiraz University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01888861
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
najmeh hejazi
Collaborators
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation, Malnutrition
Keywords
length of stay in ICU, ventilator free days

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
alpha-lipoic acid
Arm Type
Experimental
Arm Description
the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
the patients in this arm were received 900mg placebo through NG tube.
Intervention Type
Dietary Supplement
Intervention Name(s)
alpha-lipoic acid
Intervention Description
the patients in this arm receive 900mg alpha-lipoic acid through NG tube.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
the patients in this arm were received 900mg placebo through NG tube.
Primary Outcome Measure Information:
Title
length of stay in ICU
Description
number of days that patient stay in intensive care unit
Time Frame
day 28
Title
mortality
Description
percent of mortality
Time Frame
day 28
Title
ventilator free days
Description
show by days
Time Frame
10 days
Secondary Outcome Measure Information:
Title
sequential organ failure assessment score
Description
determine by SOFA score form
Time Frame
10 days
Title
insulin resistance
Description
measure by HOMA calculation equation
Time Frame
10 days
Title
malondialdehyde
Description
measure by spectrophotometery
Time Frame
10 days
Title
total antioxidant capacity
Description
measure by eliza kit
Time Frame
10 days
Title
C reactive protein
Description
measure by nephelometry method
Time Frame
10 days
Title
interleukin-6
Description
measure by eliza kit
Time Frame
10 days
Title
Albumin
Description
record from routine lab data of patients in hospital
Time Frame
10 days
Title
preAlbumin
Description
by turbidimetric assay
Time Frame
10 days
Title
Total lymphocyte count
Description
record from routine lab data of patients in hospital
Time Frame
10 days
Title
Mid arm circumference
Description
measure by non flexible meter in mid arm
Time Frame
10 days
Title
total protein
Description
record from routine lab data of patients in hospital
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Najmeh Hejazi, Ph.D
Email
n20hejazi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najmeh Hejazi, Ph.D
Organizational Affiliation
Shiraz University of Medical Sciences,Nutrition department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zohreh Mazloom, PhD
Organizational Affiliation
Shiraz University of Medical Sciences, Faculty of Nutrition
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Farid Zand, MD
Organizational Affiliation
Shiraz University of Medical Sciences, anesthesiology and critical care research center
Official's Role
Study Chair
Facility Information:
Facility Name
Shiraz University of Medical Sciences, Department of Nutrition
City
Shiraz
State/Province
Fars
ZIP/Postal Code
7157617516
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najmeh Hejazi, PhD
Email
n20hejazi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Najmeh Hejazi, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs