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IRCT20220730055585N1 IRCT 2022-08-10 Tehran University of Medical Sciences Effects of "Glucose-Insulin-Potassium" GIK Evaluation of the effects of "Glucose-Insulin-Potassium" administration on hemodynamic parameters and cardiac indices in patients admitted to the intensive care unit 2022-08-11 anticipated 50 Complete https://irct.ir/trial/65040 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Other design features: study is designed base on "before- after" method. patients evaluated before GIK administration and during the therapy, 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 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. N/A Condition 1: Hypotension, impaired hemodynamic parameters. Condition 2: Impaired cardiac indexes (heart failure). 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.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Actually, I don't see any need to publish non-identifiable personal data, so no decision has been taken in this regard. If needed, it will be evaluated and a decision will be made.
public Ali Jabbari
Anesthesia office, No#4, Sina Hospital, Hasan Abad Sqr, Emam Khomeini street, Tehran
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 dr.jabbari_a@goums.ac.ir Tehran University of Medical Sciences scientific Ali Jabbari
Anesthesia office, No#4, Sina Hospital, Hasan Abad Sqr, Emam Khomeini street, Tehran
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 dr.jabbari_a@goums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients admitted in intensive care units needing cardiovascular drug support due to systemic hypotension (shock) Decreased heart performance 18 years no limit Both 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 I95 I50.20 Hypotension Unspecified systolic (congestive) heart failure Treatment - Drugs 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. 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. 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). 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. 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). 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). 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). Tehran University of Medical Sciences Approved 2022-07-30 Research Ethics Committees of Sina Hospital Anesthesia office, No. 3 building, Sina Hospital, Emam Khomeini street, Hasan abad square Tehran Tehran Iran (Islamic Republic of)