The purpose of this study is to determine the effect of intravenous hydrocortisone in patients with refractory septic shock. This is a triple blind, randomized, placebo-controlled, single-center study. There is 80 patients in each group. Patients referred to Imam Reza (AS) hospital who have criteria for septic shock, and did not respond to vasopressor administration for more than 60 minutes are included in this study. After explanation of the study to the patients and their consents, they randomly divide into two groups. A group is treated with hydrocortisone 50 mg every 6 hours, and the other group receive placebo for 7 days. Those who suffer from adrenal insufficiency before admission or have had tuberculosis or had been treated with ketoconazole or estrogen are excluded. The patients who had no consent with this study are also excluded. Then, the response to hydrocortisone and 28-day mortality rate in two groups will be studied. Hydrocortisone respond is defined as no further need to vasopressor. Antibiotics administration time is within 1 hour of initial diagnosis of septic shock in all patients. The initial selection of antibiotics based on valid guidelines available. Continuation of antibiotic therapy will be according to culture results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080211956N2
Registration date:2014-10-19, 1393/07/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-19, 1393/07/27
Registrant information
Name
Morteza Talebi Doluee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
talebidm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous hydrocortisone in patients with refractory septic shock admitted in Imam Reza hospital
Public title
Effect of intravenous hydrocortisone in patients with septic shock
Purpose
Treatment
Inclusion/Exclusion criteria
All patients above eighteen who admitted in Imam Reza Hospital of Mashad with diagnosis of septic shock and do not respond to vasopressor therapy more than 60 minutes are included.
Those who suffer from adrenal insufficiency before admission or had tuberculosis or had been treated with ketoconazole or estrogens are excluded. Those with no consent with the plan are also excluded