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IRCT20220310054246N1 IRCT 2023-04-17 Mashhad University of Medical Sciences Evaluation of Additive effect of sodium bicarbonate with early goal-directed therapy in management of patients with severe sepsis and septic shock Evaluation of Additive effect of sodium bicarbonate with early goal-directed therapy in the first three hours of hemodynamic management of patients with severe sepsis and septic shock in intensive care units of Imam Reza hospital, Mashhad 2023-05-22 anticipated 36 Complete https://irct.ir/trial/69324 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed in a blocked manner. For this purpose, to prevent predictability of the next treatment, 15 blocks of 4 in the combination of letters A and B (ABAB, BAAB, BBAA, BABA, ABBA) and six double blocks were randomly selected and assigned to groups based on this division. Classification will be done. In order to hide the allocations, the type of treatment obtained will be placed in sealed envelopes and at the moment of treating the patients, their type of treatment will be revealed to the allocator of the sample into groups, Blinding description: The patients and the analyst and allocator of the samples will be unaware of the intervention and control groups. In order to hide the allocations, the type of treatment obtained will be placed in sealed envelopes and at the moment of treating the patients, their type of treatment will be revealed to the allocator of the sample into groups. 3 Condition 1: Severe sepsis and septic shock. Condition 2: Metabolic acidosis. Intervention 1: Intervention group: Sodium bicarbonate solution with a concentration of 7.5% in the amount of half of the deficiency calculated by the method (weight*base base*0.3) will be added to the liquid volume calculated in the amount of 30 cc of isotonic crystalloid serum per kilogram of body weight in 3 hours. Intervention 2: Control group: The calculated volume of liquid is 30 cc of isotonic crystalloid serum per kilogram of body weight in 3 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Ehsan Noori
Ebne Sina St.
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 nourie981@mums.ac.ir Mashhad University of Medical Sciences scientific Arash Peivandi Yazdi
Ebne Sina St
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 5261 peivandia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with severe sepsis Patients with septic shock Age between 18 and 80 years old 18 years 80 years Both Dissatisfaction of patients Patients with incurable diffuse malignancy Patients with alkalotic gasometry Patients receiving sodium bicarbonate prior to study entry Patients with hypernatremia Patients receiving colloidal solutions Any type of limitation in the administration of volume and sodium bicarbonate R57.8 E87.2 Other shock Acidosis Treatment - Drugs Treatment - Drugs Intervention group: Sodium bicarbonate solution with a concentration of 7.5% in the amount of half of the deficiency calculated by the method (weight*base base*0.3) will be added to the liquid volume calculated in the amount of 30 cc of isotonic crystalloid serum per kilogram of body weight in 3 hours. Control group: The calculated volume of liquid is 30 cc of isotonic crystalloid serum per kilogram of body weight in 3 hours. Investigating the possibility of increased stability of hemodynamic parameters such as blood pressure and heart rate. Timepoint: Before the intervention and three hours later. Method of measurement: Cardiac monitoring device. Investigating the possibility of improving gasometric parameters such as acidity and sodium bicarbonate. Timepoint: Before the intervention and three hours later. Method of measurement: Performing gasometry of arterial blood samples in a laboratory manner. Mashhad University of Medical Sciences Approved 2022-07-05 Ethics committee of Mashhad University of Medical Sciences Ghorashi Building, next to Hoveyzeh Cinema, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)