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IRCT20150825023760N7 IRCT 2019-02-22 Zanjan University of Medical Sciences The effect of hydrocortisone, vitamin C, and thiamine for treatment of septic shock The effect of hydrocortisone , vitamin C, and thiamine for treatment of patients with septic shock addmited to intensive care unit of Ayatollah Mousavi hospital in Zanjan , in 2017-18 2018-05-29 anticipated 58 Complete https://irct.ir/trial/31599 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study patients who met inclusion criteria were divided into intervention and control group by simple randomization method. Fiftyeghit patients with diagnosis of septic shock in critical care unit of ayatollah mousavi hospital after matching for demographic data’s and Apache 2 Score we’re divided into intervention group and control group by randomization with computerized random number tables.This method is one of basic methods for sampling in experimental studies, and frequently is used in studies with a few sample size.For randomization between two groups, random numbers table is used.In this study fiftyeghit patients with diagnosis of septic shock in critical care unit of ayatollah mousavi hospital after matching for demographic data’s and Apache 2 Score we’re divided into intervention group and control group by randomization with computerized random number tables.Fifty eight random numbers were extracted of computer by using random number table and for example 24th sample was set in intervention group and 14th sample was set in control group and this process was performed until end of the study. 3 Septic shock. Intervention 1: Intervention group: This group has received the assessed combination therapy, including hydrocortisone (50mg/each 6h, intravenously), vitamin C (1.5g/6h in 100ml DW5%, intravenously), and thiamine (200mg/12h in 50ml DW5%, intravenously)in addition to standard septic shock treatment protocols for seventy two hours. Intervention 2: Control group: This group has treated by standard septic shock treatment protocols including antibiotic therapy, prophylaxis of deep venous thrombosis, sedative medications, mechanical ventilation and prescription of vasopressor without additional intervention . Yes - There is a plan to make this available What will be shared: After the end of study,We will share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patients,clinical reports, analysis codes, and data coding systems (data Dictionary) . When: We will share our study results in 2019. To whom: The data from this study will be available to all people who can play a role in caring of septic patients, such as families, and healthcare workers. Conditions: The results of this study will be useful for care providers especially involving in septic patients admitted to intensive care units. Where to obtain: To receive information anyone can be use the following email: jamshidianes@zums.ac.ir How to obtain: we will send the results of our study to the applicants . Comments:
public Mohammadreza Jamshidi
Mousavy Hospital, Sobotie Blvd, Zanjan
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 jamshidianes@zums.ac.ir Zanjan University of Medical Sciences scientific Mohammadreza Jamshidi
Zanjan,Gavazang Ave ,Mousavy Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 jamshidianes@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) All patients with septic shock and the same Acute Physiology, Age, chronic health evaluation II (APACHE II score) admitted to intensive care unit Intubated patients Age between 18 to 70 years Serum pro-calcitonin level ≥ 2ng/ml. 18 years 70 years Both Pregnant patients R65.21 Severe sepsis with septic shock Treatment - Drugs Treatment - Drugs Intervention group: This group has received the assessed combination therapy, including hydrocortisone (50mg/each 6h, intravenously), vitamin C (1.5g/6h in 100ml DW5%, intravenously), and thiamine (200mg/12h in 50ml DW5%, intravenously)in addition to standard septic shock treatment protocols for seventy two hours. Control group: This group has treated by standard septic shock treatment protocols including antibiotic therapy, prophylaxis of deep venous thrombosis, sedative medications, mechanical ventilation and prescription of vasopressor without additional intervention . The Sequential organ function assessment (SOFA) score:a factor for evaluation of organ function. Timepoint: One day Later-Three days Later. Method of measurement: SOFA table was used to measure the performance of the organs. Serum lactate( a factor for evaluation of Oran perfusion). Timepoint: One day Later-Three days Later. Method of measurement: Lactate measurement kit was used to measure lactate. WBC count(leukocyte Count as a factor for evaluation of sepsis progression). Timepoint: One day Later-Three days Later. Method of measurement: Cell counters were used to measure the number of white blood cells. Need for vasopressors (definition of septic shock is sepsis which requires treatment with vasopressors). Timepoint: One day later-Three days later. Method of measurement: For measuring the vasopressors, the average pressure is used, the unit is micrograms per minute. Serum procalcitonin (indicator of sepsis severity). Timepoint: One day later-Three days later. Method of measurement: The measure of procalcitonin was VIDAS B.R.A.M.S PCT assy. Zanjan University of Medical Sciences Approved 2018-05-28 Ethics committee of Zanjan University of Medical Sciences Mousavi hospital,Sobotie Blvd, Zanjan Zanjan Zanjan Iran (Islamic Republic of)