Determine the effectiveness of nandrolone injection in facilitating the separation of patients under long-term mechanical ventilation
Design
A simple random sampling (Slip the Coin) with a sample size of 30 (control and control), will be in the third phase of the trial.
Settings and conduct
In the ICU of Mousavi Hospital in the area of people with long mechanical ventilation and inclusion criteria, a simple random sampling method (Slip the Coin) was applied blindly to the researcher and performer of the project (assistant investigator) in patients with the same Apache screw in Two intervention and control groups will be conducted.
Participants/Inclusion and exclusion criteria
People between the ages of 20 and 70 and those of the same sex with the same apache sclerosis are enrolled in the entry criteria, and those who have, in any case, become unstable and require additional interventions.
Intervention groups
In this study, patients who have been infected within 3 days to 3 weeks since they were inoculated or who have not been able to extol. In the range of 20 to 70 years, men and women with the same Apache scroun are randomly divided into intervention and control groups.
Each of the two groups will be at least 15 people, with a total of 30 people. For patients in the intervention group, 1 vial 25 mg of anabolic nandrolone was injected intramuscularly 2 times a day to 1 week (14 doses), and then daily weaning was evaluated, and changes in the conditions of the subjects using the checklist for the preparation of Bern's separation in both groups Control and control are measured.
Main outcome variables
Age
Sex
Device dependency time
Intervention factor
Duration of admission to ICU
Cause of hospitalization
The reason for this
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180804040695N1
Registration date:2018-10-27, 1397/08/05
Registration timing:registered_while_recruiting
Last update:2018-10-27, 1397/08/05
Update count:0
Registration date
2018-10-27, 1397/08/05
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
2018-10-23, 1397/08/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effectiveness study of nandrolone on facilitate weaning in prolonged weaning patients
Public title
Study of the effect of Nandrolone ampoule in facilitating the separation of mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with long-term separation of mechanical ventilation (over SBT 3 or 7 days from the first SBT to 3 weeks)
separate inspiration weakness (caused by myopathy or neuropathy caused by respiratory muscles for any reason).
Age 20 to 70 years
Sepsis or febrile illness that causes a kind of neuropathy.
Lack of lung disease (such as nano-pulmonary pleural effusion-respiratory failure-pulmonary mass and COPD)
Patients with the same nutrition or gavage
Length of stay in ICU less than 21 days.
No electrolyte imbalance
NIF having> 30-
Exclusion criteria:
Reintubation
Patient death before ICU clearance
NPO becoming patient during examination
Incidence of pulmonary edema, ARDS, pleural effusion and ventilator pneumonia
Electrolyte disturbances (hypokalemia, etc.) at any time during the study.
Dissatisfaction with the patient's companions
Contraindication for the injection of nandrolone such as CHF, recent history of IHD or MI, obstructive europoplasty (BPH) in men, hematocrit over 50 (erythrocytosis), and chronic kidney and liver disease (Increase LFT)
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and assistant researcher do not know which medicine was injected.
Placebo
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
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.ZUMS.REC.1397.63
Health conditions studied
1
Description of health condition studied
All patients have long-term ventilation with the same Apache screw
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Facilitate separation of ventilators in patients with long-term mechanical ventilation
Timepoint
In 3 stages, 3, 5 and 7 per week, variables such as static capacity, R.S.R.I, I.W.I, CORP Index
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
Title and more details about the data/document
Data analysis will be done using the spss v 19 software. The data will be used after the data collection in the software to describe the quantitative variables of the mean and standard deviation and describing the qualitative variables of the frequency.
In analyzing variables, for comparison of quantitative variables, following the normal T-test, otherwise, man-Witney U is used and the chi2 qualitative variables will be used.
When the data will become available and for how long
18 months
To whom data/document is available
Dr. Somayeh Abdollahi Sabet
Under which criteria data/document could be used
To analyze
From where data/document is obtainable
Dr. Somayeh Abdollahi Sabet-Medical Assistant Professor -09124195270
What processes are involved for a request to access data/document