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IRCT20101220005426N14 IRCT 2023-03-24 Kerman University of Medical Sciences Comparison of two fluid therapy methods with and without Lasix in crash injuries with lung contusion Comparison of two fluid therapy methods with and without Lasix in crash injuries with lung contusion referred to Kerman Bahonar Hospital in 2023 2023-02-20 anticipated 28 Complete https://irct.ir/trial/68174 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method in such a way that blocks of size 4. Within each block, every position will be assigned to a number selected by the random numbers table, followed by defining the two positions with smaller numbers to the intervention and with the larger numbers to the control group. This process will be reversed in the next block, Blinding description: This is a double blinded study in which people will be divided into two control and intervention groups. Participants and data analyzers will not be not aware of the allocation of the study groups. 2 Condition 1: Crush injuries. Condition 2: Lung contusion. Intervention 1: Control group: Crystalloid infusion will be initiated for the patients as a one-liter bolus over 2 hours, followed by 6 liters per day until the patients be able to tolerate enteral feeding. Intervention 2: Intervention group: The volume and pace of infusion in this group will be the same as the control group. However, at the end of hour 3 after the initiation of fluid therapy, 40 mg of furosemide (20mg/2ml, Caspian Inc., IRAN) will be injected as a bolus which will be followed by an infusion of 2mg/hour by an infusion pump. 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 There is no further information
public Ahmadinejad Mehdi
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 34 0223 5011 m.ahmadinejad@kmu.ac.ir Kerman University of Medical Sciences scientific Ahmadinejad Mehdi
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 34 0223 5011 m.ahmadinejad@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) All adult patients (over 18 years old) with multiple trauma who were diagnosed with pulmonary contusion Having creatine kinase (CPK) values over 5000 U/L Non-invasive ventilation (NIV) due to hypoxia in the emergency department of Bahonar Hospital 18 years 60 years Both Myocardial contusion Organ failure Chronic pulmonary disease Pulmonary embolism Need for massive transfusion Complications of of blood transfusion Spinal cord injury Acute kidney injury Not willing to participate in the study Death within the first 48 hours T14.7 S27.32 Crush injuries of unspecified body region Contusion of lungs Treatment - Other Treatment - Drugs Control group: Crystalloid infusion will be initiated for the patients as a one-liter bolus over 2 hours, followed by 6 liters per day until the patients be able to tolerate enteral feeding. Intervention group: The volume and pace of infusion in this group will be the same as the control group. However, at the end of hour 3 after the initiation of fluid therapy, 40 mg of furosemide (20mg/2ml, Caspian Inc., IRAN) will be injected as a bolus which will be followed by an infusion of 2mg/hour by an infusion pump. Systolic blood pressure. Timepoint: At the beginning of the study and every hour after treatment up to 48 hours. Method of measurement: Sphygmomanometer. Diastolic blood pressure. Timepoint: At the beginning of the study and every hour after treatment up to 48 hours. Method of measurement: Sphygmomanometer. Mean arterial pressure. Timepoint: At the beginning of the study and every hour after treatment up to 48 hours. Method of measurement: It is calculated based on diastolic and systolic blood pressure. Pulse rate. Timepoint: At the beginning of the study and every hour after the initiation of treatment up to 48 hours. Method of measurement: Pulse oximeter. Respiratory rate. Timepoint: At the beginning of the study and every hour after the initiation of treatment up to 48 hours. Method of measurement: Counting over a minute. Arterial partial Pressure of Oxygen (PaO2). Timepoint: At the beginning of the study and every hour after the initiation of treatment up to 48 hours. Method of measurement: Blood gas analyzer. Serum sodium. Timepoint: At the beginning of the study and every 6 hours after the initiation of treatment up to 48 hours. Method of measurement: AutoAnalyzer. Oxygen saturation (SaO2). Timepoint: At the beginning of the study and every hour after the initiation of treatment up to 48 hours. Method of measurement: Pulse oximeter. Creatine kinase. Timepoint: At the beginning of the study and every hour after the initiation of treatment up to 48 hours. Method of measurement: AutoAnalyzer. Serum creatinine level. Timepoint: At the beginning of the study and every hour after the initiation of treatment up to 48 hours. Method of measurement: AutoAnalyzer. Intake/output. Timepoint: At the beginning of the study and every 6 hours after the initiation of treatment up to 48 hours. Method of measurement: Intake /output chart. PaO2/FiO2 ratio. Timepoint: At the beginning of the study and every 6 hours after the initiation of treatment up to 48 hours. Method of measurement: Ventilator settings and ABG results. Intra-abdominal pressure. Timepoint: At the beginning of the study and every 6 hours after the initiation of treatment up to 48 hours. Method of measurement: Foley catheter attached to a manual manometer. Kerman University of Medical Sciences Approved 2022-11-09 Ethics committee, Kerman University of Medical Sciences Vice chancellor for research, Kerman University of Medical Science, Jahad street Kerman Kerman Iran (Islamic Republic of)