Evaluation of the effects of "Glucose-Insulin-Potassium" administration on hemodynamic parameters and cardiac indices in patients admitted to the intensive care unit
Determining the effects of Glucose-Insulin-Potassium (GIk) administration on hemodynamic parameters and cardiac indexes in patients with shock admitted in Intensive care unit
Design
Clinical trial with before-after design (patients will compare to themselves after prescription). Admitted patients in intensive care unit will be enrolled with simple random sampling method " randomization table" base on admission number.
Settings and conduct
Patients admitted to the intensive care units of Sina Hospital and Imam Khomeini Hospital Complex affiliated to of Tehran University of Medical Sciences with hypotension and heart failure were randomly selected; glucose-insulin-potassium mixture was prescribed to them, and hemodynamic parameters by monitoring and cardiac indices with USCOM device were evaluated.
Participants/Inclusion and exclusion criteria
Entry condition: patients admitted in intensive care units in need of medical support due to systemic hypotension (shock) and decreased heart performance.
Non-entry condition:
1. Patient non-cooperation
2. Age below 18 years
3. Diseases affecting the functioning of the cardiovascular system
4. Taking drugs that affect the performance of prescribed drugs
Intervention groups
"Insulin-glucose-potassium" mixture is prescribed to the patients admitted to the intensive care unit. The patient is evaluated in terms of hemodynamic parameters and cardiac indexes at regular intervals with USCOM device and monitoring of vital sign.
Evaluation of the effects of "Glucose-Insulin-Potassium" administration on hemodynamic parameters and cardiac indices in patients admitted to the intensive care unit
Public title
Effects of "Glucose-Insulin-Potassium"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted in intensive care units needing cardiovascular drug support due to systemic hypotension (shock)
Decreased heart performance
Exclusion criteria:
Age below 18 years old
Patients who do not participate or discontinue
Pregnancy
Brest feeding
Central nerves system and cerebrovascular disease
Anemia
Chronic kidney disease
Active bleeding
Metastatic cancer
IV drug user
Chronic alcohol user
Acute multi organ failure
Brain death
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients admitted to the intensive care unit with different disease severity and etiology. Patient entry (patient selection) was based on simple random available sampling based on patient file number and randomization table.Patients were randomly selected to enter the study based on their case number.A table of random numbers was used for randomization.If the patient was excluded from the study, the next patient was replaced by chance.The entry of patients into the study continued until reaching the desired sample size (50 patients).
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the design of the study (before-after), all patients will be the control group and the intervention group at some point in time (the changes in the parameters of patients after the administration of the drug will be compared with themselves).The patients do not know the time of the start of the study and the parameters are objective.The researcher (prescribing physician and operator of the USCOM device) is aware of the research process.The ward nurses (data collectors) and the data analyst are not aware of the study design and process.
Placebo
Not used
Assignment
Crossover
Other design features
study is designed base on "before- after" method. patients evaluated before GIK administration and during the therapy
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Sina Hospital
Street address
Anesthesia office, No. 3 building, Sina Hospital, Emam Khomeini street, Hasan abad square
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2022-07-30, 1401/05/08
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1401.051
Health conditions studied
1
Description of health condition studied
Hypotension, impaired hemodynamic parameters
ICD-10 code
I95
ICD-10 code description
Hypotension
2
Description of health condition studied
Impaired cardiac indexes (heart failure)
ICD-10 code
I50.20
ICD-10 code description
Unspecified systolic (congestive) heart failure
Primary outcomes
1
Description
Blood pressure
Timepoint
patient's entrance time to ICU, zero time (before prescription), 1h, 6h and 12h after prescription (during infusion)
Method of measurement
non invasive blood pressure - automated monitoring
2
Description
Stroke volume
Timepoint
patient's entrance time to ICU, zero time (before prescription), 1h, 6h and 12h after prescription (during infusion)
Method of measurement
Ultra sonic cardiac output monitoring (USCOM)
3
Description
Heart rate
Timepoint
patient's entrance time to ICU, zero time (before prescription), 1h, 6h and 12h after prescription (during infusion)
Method of measurement
Monitoring device
4
Description
Systemic Vascular Resistance
Timepoint
patient's entrance time to ICU, zero time (before prescription), 1h, 6h and 12h after prescription (during infusion)
Method of measurement
Ultra sonic cardiac output monitoring (USCOM)
Secondary outcomes
1
Description
Cardiac output
Timepoint
Patient's entrance time to ICU, zero time (before prescription), 1h, 6h and 12h after prescription (during infusion)
Method of measurement
Ultra sonic cardiac output monitoring (USCOM)
2
Description
Delivery Oxygen
Timepoint
Patient's entrance time to ICU, zero time (before prescription), 1h, 6h and 12h after prescription (during infusion)
Method of measurement
Ultra sonic cardiac output monitoring (USCOM)
Intervention groups
1
Description
Different patients are admitted in intensive care units with different severity and etiology. The selection of patients was done based on randomization. according to the design of the study, each patient was considered as a control group at some point of time and as an intervention group at some point. receiving Glucose-Insuline-potasium cocktail (GIK mixture); GIK cocktail infusion (insuline 15 IU+vial Kcl15% 20 mEq+Dextrose 50% 50ml) and in diabetic patients the same cocktail but Insuline 20 IU will apply. rate of infusion will be 10 ml/h for 12 hours. Cardiac index and hemodynamic parameters will evaluate in patient's entrance time to ICU, zero time (before prescription), 1 h, 6 h and 12 h after prescription (during infusion) by NIBP monitoring and USCOM device and parameters will compare before and after prescription in each one individually.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Ali Jabbari
Street address
Anesthesia office, Sina hospital, Emam khomeini street, Hasan Abad square