Our study is a phase 3 clinical trial that deals with the effect of two drugs, vitamin C and atorvastatin, on the mortality of septic shock. In reducing the mortality of septic shock, we have chosen two groups of 30 as a basis, and the patients are entered into these three groups using a random table, and by examining these two groups, we obtain the main sample size.
Settings and conduct
Our study group of patients with septic shock who will be hospitalized in Labafinejad internal intensive care unit are selected and the patients are given two study drugs that are completely matched in terms of shape, size and packaging and are cared for by the doctor. Special tests that do not know the type of drug received will be collected
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients over 18 years old
Patients with septic shock who are under norepinephrine infusion
Patients with a positive infectious culture
Patients admitted to the intensive care unit
Exclusion criteria:
Dissatisfaction
Death of the patient during the study
Intervention groups
In the intervention group, vitamin C is prescribed as one gram three times a day for 5 days, and atorvastatin 40 mg daily will be gavage to the patient.
Main outcome variables
The mortality rate of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190215042716N3
Registration date:2022-11-29, 1401/09/08
Registration timing:prospective
Last update:2022-11-29, 1401/09/08
Update count:0
Registration date
2022-11-29, 1401/09/08
Registrant information
Name
navid shafigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 3378
Email address
n.shafigh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-24, 1402/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The combined effect of statin and vitamins in patients with septic shock, a double-blind clinical trial study
Public title
The combined effect of statin and vitamins in patients with septic shock, a double-blind clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to the intensive care unit
Patients with septic shock
Exclusion criteria:
Age less than 18 years
Lack of legal consent from the patient's companions
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the inclusion criteria were selected by a random number table and by reading numbers from left to right. The numbers were between 00 and 30 in group A (intervention) (and the patients whose numbers were between 31 and 60 in group B (placebo)) The table of random numbers is a table, it is a collection of numbers that are generated completely randomly without a specific pattern or order. It is in the form of a table, and in order to use this table, the researcher must determine the direction of reading the numbers in advance and consider a default for the numbers of each intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurses will give the drugs of the 2 groups, which are completely matched in terms of shape, color and packaging, to the patients, and after that, the special care nurse, who has no knowledge of the received medicine, will collect the requested parameters of the patients, and then The information in two groups will be given to the data analyst and will be analyzed
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University od Medical Sciences
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-11-19, 1401/08/28
Ethics committee reference number
IR.SBMU.MSP.REC.1401.410
Health conditions studied
1
Description of health condition studied
Septic Shock
ICD-10 code
R57.2
ICD-10 code description
Severe sepsis with septic shock
Primary outcomes
1
Description
The mortality rate of patients
Timepoint
The time of discharge of the patient from the intensive care unit
Method of measurement
The number of group deaths
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, vitamin C is prescribed as one gram three times a day for 5 days, and atorvastatin tablets 40 mg daily will be gavage for the patient.