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IRCT20230521058246N1 IRCT 2023-10-11 Bandare-abbas University of Medical Sciences Effect of hypertonic serum in patients with hemorrhagic shock ٍEffect of hypertonic serum in patients with hemorrhagic shock 2023-07-23 anticipated 440 Complete https://irct.ir/trial/70264 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method In this method, the number of people in each study group is equal to each other during the treatment. Considering the number of 440 participants (220 in each group) and the approximate duration of 10 months to complete the study, 11 blocks of 40 will be used. The work method in this type of randomization is similar to the simple randomization method. , only the number of people during the treatment period is the same in the two treatment groups. The only drawback of this method is the identification of the last group in each block. N/A hemorrhagic shock. Intervention 1: Intervention group: Group A receives 250 ml of hypertonic saline with a concentration of 5%, and then, according to standard treatments, isotonic saline with a concentration of 0.9% is used to stabilize the patient. If the patient's condition is not stabilized, blood will be injected into the patient, and these people will be excluded from the study. Intervention 2: Intervention group: Group B receives 250 ml of isotonic saline with a concentration of 0.9%, and then, if required, according to standard treatments, the amount of fluid received is increased until the patient is stabilized, and if the patient's condition is not stable, blood is injected, in this case, the patient will be excluded from the study. 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 Dr. Sadegh Ahmadi Rashti
Educational and Research Complex of the Great Prophet,Shahid Mohammad Hospital, Jomhory Blvd,Old Airport,Iran
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 937 971 1740 66sadegh66@gmail.com Bandare-abbas University of Medical Sciences scientific Dr. Sadegh Ahmadi Rashti
Educational and Research Complex of the Great Prophet,Shahid Mohammad Hospital, Jomhory Blvd,Old Airport,Iran
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 937 971 1740 66sadegh66@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) People with hemorrhagic trauma confirmed by a physician 18 years or older people In people exposed to penetrating or blunt trauma one hour before randomization In people with systolic blood pressure ≤100 mm Hg In people with informed consent regarding participation in the research In people with a decrease in blood volume (more than 1000 ml) 18 years no limit Both Patients with a history of high blood chloride Patients with a history of high sodium levels in the blood Patients with a history of high potassium levels in the blood Patients with a history of kidney dysfunction Patients with a history of pregnancy Patients with a history of epilepsy Patients with a history of blood coagulation-related diseases Patients with a history of liver disease Patients with a history of a severe decrease in body temperature to less than 28 degrees Celsius Patients with a history of inability to receive IV Patients with a history of absence of cardiac sinus rhythm Patients with a history of cardiac arrest Patients with a history of cardiopulmonary resuscitation Patients with a history of burns of more than 20% of the body surface Patients with a history of increased intracranial pressure Patients with a history of anaphylactic reactions Patients with tissue or cellular dehydration Patients with a history of receiving more than 2 liters of crystalloid before the study began Patients with a history of suffocation caused by hanging Patients transferred from other hospitals Patients with excessive delay in the treatment process R58 Hemorrhage, not elsewhere classified Treatment - Other Treatment - Other Intervention group: Group A receives 250 ml of hypertonic saline with a concentration of 5%, and then, according to standard treatments, isotonic saline with a concentration of 0.9% is used to stabilize the patient. If the patient's condition is not stabilized, blood will be injected into the patient, and these people will be excluded from the study. Intervention group: Group B receives 250 ml of isotonic saline with a concentration of 0.9%, and then, if required, according to standard treatments, the amount of fluid received is increased until the patient is stabilized, and if the patient's condition is not stable, blood is injected, in this case, the patient will be excluded from the study. The primary outcome of this study include a decrease in the mortality rate of patients due to hemorrhagic shock during the intervention period. Timepoint: Upon discharge. Method of measurement: Patient's File. Reducing the length of hospital stay. Timepoint: Upon discharge. Method of measurement: Patient's File. Reducing the length of ICU stay. Timepoint: Upon discharge. Method of measurement: Patient's File. Reducing the volume of blood and fluids received. Timepoint: After intervention. Method of measurement: Check list and patient's file. Bandare-abbas University of Medical Sciences Approved 2023-04-24 Ethics Committee of Hormozgan University of Medical Sciences Research and Technology vice-chancellor Building,Hormozgan University of Medical Science Campus,Imam Hossein Blvd,Bandar Abbas,Iran Bandar Abbas Hormozgan Iran (Islamic Republic of)