Objective: Evaluation the effect of co-enzyme Q10 on oxidative stress, inflammatory biomarkers and outcome of patients with sepsis.
Design: Randomized, double-blind, placebo controlled clinical trial
Setting: Patients with sepsis hospitalized at intensive care unit of Alzahra hospital affiliated to Isfahan University of Medical Sciences.
Major Inclusion and Exclusion criteria: All patients older than 18 years old who have at least two criteria of SIRS (Systemic Inflammatory Response Syndrome) plus proved or suspected infection and also APACHE II score greater than 15 will be enrolled in the study. Patients with coaglupathy and pregnancy will be excluded.
Intervention: Eligible patients will be randomized to drug and placebo groups. Patients in drug group will be received co-enzyme Q10, 60 mg twice daily for 7 days. Both groups will be received standard sepsis treatment.
Main outcome measures: Changes in bio marker levels before and after drug administration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504051497N4
Registration date:2015-07-06, 1394/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Sarah Mousavi
Name of organization / entity
Clinical Pharmacy Department, Pharmacy Faculty, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2567
Email address
smousavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of coenzyme Q10 on oxidative stress, inflammatory factors, and outcome of septic patients
Public title
Evaluation the effecte of coenzyme Q10 in patients with sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Critically ill patients with sepsis (proved or suspected infection) plus at least 2 criteria from following conditions:Body temperature >38.3 c or <36 c, Heart rate > 90 beat/min, Respiratory rate >20 breath/min or PaCO2 < 32 mmHg, White blood cells (WBC) > 12000 cell/mm3, or < 4000 cell/mm3, or >10% immature [band]cells, Sudden change of mental status, and Hypoglycemia (blood glucose<120 mg/dl in the absence of diabetes); APACHE II score ≥15 on admission day; Availability of oral route administration; Consent of the patients or their relatives.
Exclusion criteria:
Pregnancy; End-stage or DNR (Do Not Resuscitate) patients; Patients enrolled in other studies; Coaglupathy (INR>2)
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block randomization will performed in random blocks of two to eight
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
د/4/6450
Health conditions studied
1
Description of health condition studied
Sepsis/septic shock
ICD-10 code
R57.2 (Sep
ICD-10 code description
Septic shock
Primary outcomes
1
Description
Changes in biomarkers levels before and after intervention
Timepoint
Day 1, 3 and 7 of admission
Method of measurement
ELIZA Kit
Secondary outcomes
1
Description
Hospital lenght of stay
Timepoint
Until the end of hospital stay
Method of measurement
Day
2
Description
Duration of mechanical ventilation
Timepoint
Until extubation
Method of measurement
Day
3
Description
Mortality rate
Timepoint
Day 7 and 28
Method of measurement
Day
Intervention groups
1
Description
Patients in intervention group will receive co enzyme Q10 60 mg (two 30 mg capsules) (Nature made Co., USA) two times per day for 7 days. Both groups also will receive standard sepsis treatment based on international guidelines.
Category
Treatment - Drugs
2
Description
Patients in control group will receive placebo (which will produce by pharmacy faculty) two times per day for 7 days. Both groups also will receive standard sepsis treatment based on international guidelines.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sarah Mousavi
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Alzahra Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Grant name
5005/4/د
Grant code / Reference number
193114
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research,Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr Sarah Mousavi
Position
PhD
Other areas of specialty/work
Street address
Hezar Jerib avenue, Isfahan University of Medical Science, Isfahan
City
Isfahan
Postal code
73461-81746
Phone
+98 317922567
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Sarah Mousavi
Position
PhD
Other areas of specialty/work
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 317922567
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)