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IRCT20230701058635N1 IRCT 2024-02-16 Tehran University of Medical Sciences Effect of early adminestration of corton in sepsis Evaluating effect of early adminestration of corticosteroid in sepsis; A randomized clinical triali 2024-01-21 anticipated 40 Complete https://irct.ir/trial/71014 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done according to the block randomization method. regarding the sample size, 4 patients will be included in each group. Randomization groups generally are AABB, ABAB, ABBA, BABA, BAAB, and BBAA. Rndom numbers will be generate using Excel sofware, Blinding description: Intravenous hydrocortisone and saline will be prepared and labelled by a technician who is not involved in the study. As complete solubility of hydrocortisone in saline; without any distinct color and smell, same volume of saline will be labelled as control. Patient, physician an clinical evaluator are not aware regarding syringes contents. 3 sepsis. Intervention 1: Concomitant with the standard of care (fluid resuscitation, antibiotic therapy, management of electrolytes and acid-base disturbances and metabolic supports) patients will receive intravenous hydrocortisone 50 mg every 6-hour for up to 48 hours. Intervention 2: Control group: Concomitant with the standard of care (fluid resuscitation, antibiotic therapy, management of electrolytes and acid-base disturbances and metabolic supports) patients will receive 4-ml placebo as intravenous injection every 6-hour for up to 48 hours. Yes - There is a plan to make this available What will be shared: Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript When: One year after finishing the study, data will be published and will be available in databases To whom: After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes Conditions: Other researchers are permitted to included the results in their systematic reviews and metaanalysis Where to obtain: For this you may ask from scientific responsible person. How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks Comments:
public Ehsan Emami
Department of clinical pharmacy, Faculty of Pharmacy, Tehran University of Medical Science, 16 Azar Ave
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6670 2171 e-EMAMI@student.tums.ac.ir Tehran University of Medical Sciences scientific Ehsan Emami
Department of Clinical Pharmacy,Faculty of Pharmacy, Tehran University of Medical Science, 16 Azar Ave
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6670 2171 e-EMAMI@student.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age of 18–89 years Systolic blood pressure of <90 mmHg or plasma lactate level of >2 mmol/L SOFA score of ≥2 points consequent to the infection 18 years 89 years Both Rejection of sepsis diagnosis after initial evaluations Decision to limit or withdraw treatment Steroid use within 4 weeks Chemotherapy for underlying malignancy within 4 weeks Etomidate use during hospitalization Pregnancy or lactation Informed written consent cannot be obtained from a patient or legal representative Corticosteroides contraindications R65.1 Systemic Inflammatory Response Syndrome of infectious origin with organ failureSevere sepsis Prevention Treatment - Drugs Concomitant with the standard of care (fluid resuscitation, antibiotic therapy, management of electrolytes and acid-base disturbances and metabolic supports) patients will receive intravenous hydrocortisone 50 mg every 6-hour for up to 48 hours. Control group: Concomitant with the standard of care (fluid resuscitation, antibiotic therapy, management of electrolytes and acid-base disturbances and metabolic supports) patients will receive 4-ml placebo as intravenous injection every 6-hour for up to 48 hours. Time to enter the septic shock. Timepoint: Every 1-hour. Method of measurement: According mean artrial pressure. Vasopressor requirement. Timepoint: Every 1-hour. Method of measurement: Starting a vasopressor drug (type and dose). Need for mechanical ventilation support. Timepoint: Every 1-hour. Method of measurement: Patient intubation. 7-day mortality. Timepoint: 7 days after initial treatment. Method of measurement: patient follow-up. 28-day mortality. Timepoint: 28 days after initial treatment. Method of measurement: patient follow-up. Length of stay in ICU. Timepoint: Daily. Method of measurement: patient follow-up. Tehran University of Medical Sciences Approved 2023-06-28 Ethics committee of Tehran University of Medical Sciences Ghods Ave. Tehran University of Medical Science Tehran Tehran Iran (Islamic Republic of)