This study is a Randomized Clinical Trial on 30 patients in intensive care unit (Sina hospital). Patients older than 16 years of age who has septic shock that is resistant to fluids (as defined by lack of response to 500 ml of normal saline or a requirement for vasopressor) will enter to the study and those with history of CHD, underlying chronic heart disease (NYHA class III or IV), severe hyponatremia (serum sodium less than 130 mEq/L), acute mesenteric ischemia, pregnancy or patient or legal guardian who does not consent for enrollment will exclude. Patients will randomly assign in two groups. Group one will receive infusion of 0.01-0.03u/min of vasopressin and group two 5-15 mcg/min of norepinephrine. All vasopressors infusions will titrate and tapered to maintain a target blood pressure. Patients in each group will receive the standard treatment for shock. Each patient will be monitored for 48 hours and four blood samples will be taken, first one before vasopressor administration and the other three in 12 hours, 24 hours and 48 hours. Blood samples will be used for assessment of Interleukin-1, Interleukin-6 ,Tumor Necrosis Factor-Alpha, Angiopoietin 1-2, C- Reactive Protein, and pentraxin-3
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100311002N1
Registration date:2012-10-16, 1391/07/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-10-16, 1391/07/25
Registrant information
Name
Elchin Barzegar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
barzegar@clinicalpharmacy.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Vasopressin versus Norepinephrine in vascular damage biomarkers in patients with septic shock
Public title
Effects of Vasopressin in Septic Shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients older than 16 years of age who has septic shock that is resistant to fluids (as defined by lack of response to 500 ml of normal saline or a requirement for vasopressor) within 48 hours.
Exclusion criteria: Patients less than 16 years of age; history of CHD; underlying chronic heart disease (NYHA class III or IV); severe hyponatremia (serum sodium less than 130 mEq/L); acute mesenteric ischemia; pregnancy; Patient or legal guardian does not consent for enrollment
Age
From 16 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Theran University of Medical Sciences
Street address
6th Floor, Tehran University of Medical Sciences Central Organization, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-09-04, 1391/06/14
Ethics committee reference number
91-02-33-18310-63707
Health conditions studied
1
Description of health condition studied
Septic shock
ICD-10 code
R57.2
ICD-10 code description
Septic shock
Primary outcomes
1
Description
Tumor Necrosis Factor-Alpha
Timepoint
before vasopressor administration and in 12 hours, 24 hours and 48 hours
Method of measurement
Elisa
2
Description
Interleukin-1
Timepoint
Before vasopressor administration and in 12 hours, 24 hours and 48 hours
Method of measurement
Elisa
3
Description
Interleukin-6
Timepoint
Before vasopressor administration and in 12 hours, 24 hours and 48 hours
Method of measurement
Elisa
4
Description
Pentraxin-3
Timepoint
Before vasopressor administration and in 12 hours, 24 hours and 48 hours
Method of measurement
Elisa
5
Description
Angiopoietin-1
Timepoint
Before vasopressor administration and in 12 hours, 24 hours and 48 hours
Method of measurement
RIA
6
Description
Angiopoietin-2
Timepoint
Before vasopressor administration and in 12 hours, 24 hours and 48 hours
Method of measurement
Elisa
7
Description
CRP
Timepoint
Before vasopressor administration and in 12 hours, 24 hours and 48 hours
Method of measurement
Elisa
8
Description
Lactate
Timepoint
Before vasopressor administration and in 12 hours, 24 hours and 48 hours
Method of measurement
Calorimetric assay
Secondary outcomes
1
Description
Mortality
Timepoint
Daily
Method of measurement
SAPSII
2
Description
Organ dysfunction
Timepoint
Daily
Method of measurement
MODS
3
Description
MAP
Timepoint
every 3 hours
Method of measurement
NIBP
Intervention groups
1
Description
Group one will receive infusion of 0.01-0.03u/min of vasopressin. vasopressin infusions will titrate and tapered to maintain a target blood pressure. This intervention will continue for 48 hours
Category
Treatment - Drugs
2
Description
Group two will receive infusion of 5-15 mcg/min of norepinephrine. Norepinephrine infusions will titrate and tapered to maintain a target blood pressure. This intervention will continue for 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mojtaba Mojtahedzadeh Pharm.D
Street address
31st shahriver square, Imam khomeyni street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Saedi
Street address
Enghelab Ave, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Elchin Barzegar
Position
Pharm.D/Clinical pharmacy resident
Other areas of specialty/work
Street address
Department of Clinical Pharmacy (Pharmacotherapy), Pharmacy Faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
elchin.barzegar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Mojtahedzadeh
Position
Pharm D, BCPS/Professor
Other areas of specialty/work
Street address
Department of Clinical Pharmacy (Pharmacotherapy), Pharmacy Faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
mojtahed@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elchin Barzegar
Position
Pharm.D/Clinical pharmacy resident
Other areas of specialty/work
Street address
Department of Clinical Pharmacy (Pharmacotherapy), Pharmacy Faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
elchin.barzegar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)