History
# Registration date Revision Id
2 2019-12-14, 1398/09/23 119743
1 2016-10-13, 1395/07/22 20733
Changes made to previous revision
This is the first revision

Protocol summary

Summary
In this study the therapeutic effects of dopamine and nor-epinephrine on pressure of tidal carbon dioxide (ETCO2) was evaluated in patients with septic shock. This study was undertaken in an educational hospital on 40 patients. Patients enrolled in this study include people over 18 years who suffer from septic shock. Shock criteria means arterial pressure less than 70 mm Hg or systolic pressure less than 100 mm Hg and reduced tissue perfusion symptoms, despite administration of at least 1 liter of crystallized solutions will be considered. Persons under 18 years, who received more than 4 hours vasopressor recent episode of shock, severe heart arrhythmia and those with brain death and traumatic patients, were excluded. Patients were divided into 2 groups and individuals in each group were randomized using random numbers table for in each group. The first group received the drug nor-epinephrine, and second group received dopamine. Data include age, sex, primary systolic blood pressure, 30 minutes and 120 minutes after start of treatment and ET-CO2 primary 30 minutes and 120 minutes after ET-CO2 were measured and recorded. The effects of each of these two drugs in treating the symptoms, hemodynamic shock and increasing the amount of ETCO2 were assessed and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101924606N1
Registration date: 2016-10-13, 1395/07/22
Registration timing: registered_while_recruiting

Last update:
Update count: 1
Registration date
2016-10-13, 1395/07/22
Registrant information
Name
Hamed Aminiahidashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
h.aminiahidashti@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-02-18, 1394/11/29
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Dopamine and Nor-epinephrine on End tidal carbon dioxide pressure in patients with septic shock
Public title
End tidal carbon dioxide pressure in patients with septic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:all the patients admitted to emergency department with septic shock criteria Exclusion criteria:patients under 18 years and more than 75 years؛ Those who received more than 4 hours vasopressor drugs؛ Those with severe cardiac arrhythmia؛ brain death؛ Traumatic patient
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Jooybar treeway, Imam Square
City
Sari
Postal code
4815724971
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.MAZUMS.REC.95.1547

Health conditions studied

1

Description of health condition studied
Septic Shock
ICD-10 code
A41.9
ICD-10 code description
Septicaemia, unspecified, Septic Shock

Primary outcomes

1

Description
Blood pressure
Timepoint
Before intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
mmhg, manometer

2

Description
End Tidal Carbon Dioxide Pressure
Timepoint
Before intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
mmhg, capnograph

Secondary outcomes

1

Description
Heart Rate
Timepoint
Before intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
number per minutes

2

Description
Oxygen Saturation
Timepoint
Before intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
Puls oxymeter

3

Description
Carbon Dioxide Pressure
Timepoint
Before intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
Blood gas

4

Description
Oxygen Pressure
Timepoint
Before intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
Blood gas

Intervention groups

1

Description
Amp Neurepinephrine, 0.5 micro gram/kilogram/minutes, For 2 hours
Category
Treatment - Drugs

2

Description
Amp Dopamine, 5microgram/kilogram/minutes, For 2 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmadali Enayati
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for researche, Mazandaran University of Medical Siences
Full name of responsible person
Ahmadali Enayati
Street address
Vice chancellor for researche, Mazandaran University of Medical Siences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for researche, Mazandaran University of Medical Siences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Hamed Aminiahidashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospital, Amirmazandarani avenue
City
Sari
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
Email
h.aminiahidashti@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamed Aminiahidashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospital, Amirmazandarani avenue
City
Sari
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
Email
h.aminiahidashti@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamed Aminiahidashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospita, Amirmazandarani avenue
City
Sari
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
Email
h.aminiahidashti@mazums.ac.ir
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
Loading...