The effect of Steroids (Hydrocortisone), Thiamine and Ascorbic Acid Supplementation in Septic Shock (STASIS) in hospitalized patients in intensive care unit : A Prospective, triple-blinded, Randomized, Controlled clinical trail

To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care versus standard care in septic shock confers an in-hospital and 28-day mortality benefit

A triple blinded, randomized, parallel clinical trial with control group

A multi-center (Baqiyatallah, Sina, Shariati, Imam khomeini, and Masih daneshvari hospitals in Tehran and Besat hospital in Hamadan), triple-blinded (Patient, data collector researcher, and statistician), two groups (intervention and control) clinical trial will be conducted by convenience sampling and then, random allocation using four-block in suffering hospitalized patients in medical and surgical (general) intensive care unit from septic shock. In the intervention group, patients will receive three hydrocortisone, thiamine, and ascorbic acid drugs along with routine treatment and the control group will receive routine treatment.

Inclusion Criteria • Septic shock • Age ≥ 18 years Exclusion Criteria • Age < 18 years • Pregnant • Patients with limitation of care (i.e. do not resuscitate [DNR]) • Known Glucose-6-Phosphate Dehydrogenase (G6PD)Deficiency • Excluding primary admission diagnosis including the following: acute stroke; acute coronary syndrome; active gastrointestinal bleed; burn; trauma • Vasopressor use prior to randomization for more than 24 hours

Intervention group: Receiving three drugs hydrocortisone, thiamine and ascorbic acid along with standard care and Control group: Receiving standard care

Primary: 28-day mortality rate Secondary: (1) More rapid improvements in illness severity (2) Greater changes in biochemical profiling (3) Improved hospital stay metrics

Block randomization (groups of 2) will be performed using random numbers list generated by Random Allocation Software © (RAS; Informer Technologies, Inc., Madrid, Spain). The numbers will be placed into sequential containers that will be kept in a secure location until allocation consignment. Enrollment and randomization will be occurred in the emergency department from available admitted ICU patients on a convenience basis. Only patients will be admitted to the ICU through the emergency department will be eligible for inclusion. The consignment will be implemented though: A person who divides patients into control and intervention groups will not be aware of the grouping of individuals.

To ensure blinding, the allocation sequence will be kept by a different investigator than the one enrolling participants. A third investigator will be responsible for patient follow-up and assessments. Patients will not know what group they are in. Nurses, researchers, and data collectors will not be aware of patient grouping. The two intervention and control groups will not be specified for the statistician.

Confidentiality of information