Protocol summary
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Study aim
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comparing the effect of using norepinephrine or dopamine on ETco2 of patients with infectious shock
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Design
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394/5000
The first group received epinephrine light medication and the second group received dopamine. Age, sex, blood pressure at baseline and 30 minutes and 120 minutes after treatment and initial ET-CO2 and ET-CO2 at 30 and 120 minutes, respectively. It is then measured and recorded, and then the effects of each of the two drugs mentioned above in treating shock based on improved hemodynamic symptoms and increased CO2 levels are compared and compared.
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Settings and conduct
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The study will be conducted in Imam Khomeini hospital of sari a training center on 138 patients with depressive disorder.
The drugs were formulated and put in a separate container and then given a separate code for each container. The physician, nurse, and patient were unaware of the type of medication, and the patients were randomized based on simple random
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Participants/Inclusion and exclusion criteria
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The inclusion criteria comprised patients aged 18 years or older, undergone mechanical ventilation, and required vasopressor (dopamine or norepinephrine) for shock therapy
patients under 18 years of age, with trauma, chronic lung disease, definite brain death, cardiac arrhythmia, referred from other centers, or with more than 2-hour hospitalization in the emergency department were excluded from the study.
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Intervention groups
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The first group of epinephrine
The second group is dopamine
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Main outcome variables
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ETco2 Measurement
General information
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Reason for update
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Modify the number of study samples
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015101924606N1
Registration date:
2016-10-13, 1395/07/22
Registration timing:
registered_while_recruiting
Last update:
2020-01-28, 1398/11/08
Update count:
1
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Registration date
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2016-10-13, 1395/07/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Mazandaran University of Medical Sciences
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Expected recruitment start date
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2016-02-18, 1394/11/29
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Expected recruitment end date
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2017-02-18, 1395/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison Dopamine and Nor-epinephrine on End tidal carbon dioxide pressure in patients with septic shock
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Public title
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End tidal carbon dioxide pressure in patients with septic shock
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with septic shock conditions
Exclusion criteria:
patients under 18 years
patients more than 75 year
Those who received more than 4 hours vasopressor drugs brain death
Those with severe cardiac arrhythmia
Traumatic patient
Brain death
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
138
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization
Patients were divided into two groups and randomly assigned to each of the two groups. The drugs in each group were of the same size and shape, each of these numbers was coded and sealed in a seal envelope.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Drugs in a similar container in an opaque bag numbered and the prescribing physician and nurse practitioner were unaware.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-17, 1395/04/27
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Ethics committee reference number
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IR.MAZUMS.REC.95.1547
Health conditions studied
1
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Description of health condition studied
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Septic Shock
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ICD-10 code
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A41.9
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ICD-10 code description
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Septicaemia, unspecified, Septic Shock
Primary outcomes
1
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Description
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Blood pressure
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Timepoint
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Before intervention, 30 minutes after intervention, 120 minutes after intervention
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Method of measurement
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mmhg, manometer
2
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Description
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End Tidal Carbon Dioxide Pressure
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Timepoint
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Before intervention, 30 minutes after intervention, 120 minutes after intervention
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Method of measurement
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mmhg, capnograph
Secondary outcomes
1
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Description
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Heart Rate
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Timepoint
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Before intervention, 30 minutes after intervention, 120 minutes after intervention
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Method of measurement
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number per minutes
2
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Description
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Oxygen Saturation
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Timepoint
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Before intervention, 30 minutes after intervention, 120 minutes after intervention
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Method of measurement
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Puls oxymeter
3
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Description
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Carbon Dioxide Pressure
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Timepoint
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Before intervention, 30 minutes after intervention, 120 minutes after intervention
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Method of measurement
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Blood gas
4
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Description
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Oxygen Pressure
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Timepoint
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Before intervention, 30 minutes after intervention, 120 minutes after intervention
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Method of measurement
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Blood gas
Intervention groups
1
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Description
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Amp Neurepinephrine, 0.5 micro gram/kilogram/minutes, For 2 hours
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Category
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Treatment - Drugs
2
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Description
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Amp Dopamine, 5microgram/kilogram/minutes, For 2 hours
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sari University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All potential data is shared after unidentifiable people
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When the data will become available and for how long
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It has started in 2016
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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All data analysis and actions are coordinated and informed by the project manager
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From where data/document is obtainable
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Project Officer - Research Deputy of Mazandaran University of Medical Sciences
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What processes are involved for a request to access data/document
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Written Request to Research Deputy of Mazandaran University of Medical Sciences
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Comments
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