Protocol summary

Study aim
Determining the effect of Metoral in reducing the death of septic patients admitted to the intensive care unit.
Design
Septic patients over 18 years of age admitted to ICU wards by simple randomization with random number table divided into intervention and control groups, clinical trial, with parallel group, one-way blind, phase 2 on 36 patients.
Settings and conduct
Septic patients in ICU of Mousavi Hospital were simple randomly divided into 2 groups, the intervention group, receiving 25 mg metoral tablets every eight hours for 7days one-sided blind.others not receive metoral.Then lab indicators and the 14-day mortality of patients are determined
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years of age admitted to the ICU wards of Ayatollah Mousavi Hospital in Zanjan with a diagnosis of sepsis that has not been diagnosed for more than forty-eight hours. Inclusion criteria: Age under 18 years. Pregnancy. More than forty-eight hours have passed since the diagnosis of sepsis. Acute heart failure, AV block, bradycardia (heart rate below 70 beats per minute), heart shock, hypotension (systolic pressure below 90 mm Hg), pulmonary edema, patient sinus syndrome, ventricular dysfunction, acute bronchospasm, asthma, bronchitis Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Pulmonary Disease, Peripheral Artery Disease, Raynaud's Phenomenon, Vasospastic Angina, Lactation, Pheochromocytoma, Myasthenia Gravis, Liver Disease
Intervention groups
Intervention group: septic patients in the intensive care unit, who were selected by simple randomization, receive 25 mg oral metoral tablets every eight hours for seven days with vital sign control.Control group:patients met the same criteria but did not receive metoral.
Main outcome variables
Blood pressure; Heart rate; Left ventricular ejection fraction; Sequential Organ Failure Assessment; 14 day mortality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180804040695N2
Registration date: 2022-02-20, 1400/12/01
Registration timing: prospective

Last update: 2022-02-20, 1400/12/01
Update count: 0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
Mohammadreza Zeraati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0000
Email address
mohammadrezazeraati@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of the metoprolol in mortality rate reduction in septic patients admitted to ICU ward
Public title
The effect of metoprolol on reducing mortality in septic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
over 18 y admitted in the ICU wards of Ayatollah Mousavi Hospital in Zanjan Diagnosis of sepsis less than forty-eight hours after diagnosis
Exclusion criteria:
Pregnancy Acute heart failure AV block bradycardia (heart rate below 70 beats per minute) heart shock hypotension (systolic pressure below 90 mm Hg) pulmonary edema sick sinus syndrome ventricular dysfunction acute bronchospasm asthma bronchitis Chronic Obstructive Pulmonary Disease (COPD) Emphysema Pulmonary Disease Peripheral Artery Disease Raynaud's Phenomenon Vasospastic Angina Brest feeding Pheochromocytoma Myasthenia Gravis Liver Diseases
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using coin toss. Sampling is available and included in the study with the patient's hospitalization, and since we have only two small 18-digit intervention and control groups, assignment to each group is simple random and by tossing coins and taps for each patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient under intervention will be unaware of the type of treatment due to the reduced level of consciousness in the intensive care unit.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences , Azadi Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.ZUMS.REC.1400.298

Health conditions studied

1

Description of health condition studied
sepsis
ICD-10 code
A41
ICD-10 code description
other sepsis

Primary outcomes

1

Description
Mortality rate of septic patients
Timepoint
Two weeks after the start of the intervention
Method of measurement
Refer to the medical file

2

Description
Heart rate
Timepoint
Every six hours until the end of a week
Method of measurement
cardiac monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving routine treatment of sepsis in addition to receiving 25 mg oral metoprolol tablets of Alborz Drug Company every eight hours for seven days with regular control of vital signs.
Category
Treatment - Drugs

2

Description
Control group: Receive routine treatment of sepsis.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Specialized and Sub-Specialized Educational and Medical Center
Full name of responsible person
Mohammad Reza Zeraati
Street address
Ayatollah Mousavi Specialized and Sub-Specialized Educational and Medical Center, Gavazang Road, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3313 0000
Email
mohammadrezazeraati@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
dr. Maziar Peyda
Street address
Ayatollah Mousavi Specialized and Sub-Specialized Educational and Medical Center, Gavazang Road, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Zeraati
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavi Specialized and Sub-Specialized Educational and Medical Center, Gavazang Road, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3313 0000
Email
mohammadrezazeraati@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Zeraati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavi Specialized and Sub-Specialized Educational and Medical Center, Gavazang Road, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3313 0000
Email
mohammadrezazeraati@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Zeraati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavi Specialized and Sub-Specialized Educational and Medical Center, Gavazang Road, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3313 0000
Email
mohammadrezazeraati@zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
publishing article
When the data will become available and for how long
Over the next year
To whom data/document is available
Public access
Under which criteria data/document could be used
For research
From where data/document is obtainable
Magazine office
What processes are involved for a request to access data/document
Searching in Internet
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