Protocol summary

Summary
Propose: Assessment of intermittent and continuous infusion dose of N-acetylcysteine (NAC) on oxidative stress levels and total antioxidant capacity of the body in septic patients admitted to the ICU. This study is prospective, randomize, single blind and clinical trial, 60 patients were randomly divided in three groups with using a random number table(the patient and nurse were blind about the drug). Intervention group 1 received 25 mg/kg intravenous bolus N-acetyl cysteine (NAC) at the beginning and then 25 mg/kg every 8 hours for 24 hours (total 100 mg/kg during the 24 hours). Intervention group 2 received 25 mg/kg intravenous bolus N-acetyl cysteine (NAC) at the beginning and then 75 mg/kg intravenous NAC as a continuous infusion over 24 hours (total 100 mg). In the placebo group received 100 mg/kg saline. Inclusion criteria: patients with systemic inflammatory response syndrome, infection (sepsis) admitted to the ICU. Exclusion criteria: lack of patient consent to participate in the study; Taking any supplements such as vitamins with antioxidant properties known as C, E, A, trace elements zinc, manganese, selenium, and NAC before entering the study; NAC drug contraindications for any reason. Primary outcome: total antioxidant capacity and the level of Lipid peroxide serum. To measure the total antioxidant capacity of serum and level of Lipid peroxide serum was used Cayman company kits.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512118384N6
Registration date: 2017-04-07, 1396/01/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-07, 1396/01/18
Registrant information
Name
Arash Peivandi Yazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
peivandia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Mashhad University of Medical Sciences
Expected recruitment start date
2014-11-06, 1393/08/15
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial assessment of intermittent and continuous infusion dose of N-acetylcysteine on oxidative stress levels and total antioxidant capacity of the body in septic patients admitted to the ICU
Public title
Assessment of intermittent and continuous infusion dose of N-acetylcysteine on oxidative stress levels and total antioxidant capacity of the body in septic patients admitted to the ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with systemic inflammatory response syndrome, infection (sepsis) admitted to the ICU Exclusion criteria: lack of patient consent to participate in the study; Taking any supplements such as vitamins with antioxidant properties known as C, E, A, trace elements zinc, manganese, selenium, and NAC before entering the study; NAC drug contraindications for any reason
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2014-10-25, 1393/08/03
Ethics committee reference number
922675

Health conditions studied

1

Description of health condition studied
Sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified

Primary outcomes

1

Description
total antioxidant capacity
Timepoint
Baseline and 24 hours after completion of the study or the same time
Method of measurement
Using Cayman kits Company

2

Description
level of Lipid peroxide serum
Timepoint
Baseline and 24 hours after completion of the study or the same time
Method of measurement
Using Cayman kits Company

Secondary outcomes

empty

Intervention groups

1

Description
The first Intervention group received 25 mg/kg intravenous bolus on the N-acetyl cysteine (NAC) at the beginning and then 25 mg/kg every 8 hours for 24 hours (total 100 mg/kg during the 24 hours
Category
Treatment - Drugs

2

Description
The second Intervention group received 25 mg/kg intravenous bolus on the N-acetyl cysteine (NAC) at the beginning and then 75 mg/kg intravenous NAC as a continuous infusion over 24 hours (total 100 mg).
Category
Treatment - Drugs

3

Description
Control group: received 100 mg/kg saline
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Peivandi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street
City
Mashhad
Postal code
Phone
+98 51 3802 2711
Fax
Email
PeivandiA@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Arash Peivani Yazdi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street
City
Mashhad
Postal code
Phone
+98 51 3802 2711
Fax
Email
PeivandiA@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Arash Peivandi Yazdi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street
City
Mashhad
Postal code
Phone
+98 51 3802 2711
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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