Effects of Hydrocortison Treatment on Angiotensin II and Angiotensin II Receptors in Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the role of angiotensin II, AT1, and AT2 on catecholomine responsive and catecholomine resistant septic shock, and the effect of hydrocortisone traetment on catecholomine resistant septic shock and angiotensin II, AT1, and AT2.Angiotensin II can be used as a biomarker of vasoplegia observed in refractory septic shock unresponsive to catecholamine. In these patients; therapeutic effect of hydrocortisone on hypotension was performed by decreasing AT 2 level, AT2 should be investigated as a therapeutic target in the treatment of vasoplegia-induced hypotension and SVRI measured by minimally invasive cardiac output method suggests that it can be used as a useful parameter in the diagnosis and follow-up of vasoplegia.

Detailed Description
-----------------
This study will be enrolled 40 patients diagnosed with septic shock according to Sepsis 3 criteria. The patients with septic shock who needed a noradrenaline infusion rate of up to 0.5µg/kg/min to maintain MAP>65 mmHg will be classified as control group (n=20) and the ones who required a noradrenaline infusion rate above 0.5µg/kg will be classified as hydrocortisone group (n=20). Blood samples will be taken for analysis of plasma angiotensin II, AT1, AT2 levels at the time of diagnosis, one hour after and on the 3rd day of the bundle and the hydrocortisone treatment. Hemodynamic parameters simultaneously obtain by continuous minimal invasive cardiac output measurement method will record.

Official Title
-----------------
The Effect of Hydrocortison Treatment on Angiotensin II and Angiotensin Receptors in Patients Suffering From Septic Shock: A Prospective Observational Study

Conditions
-----------------
Shock, Septic

Intervention / Treatment
-----------------
* Drug: Drug Steroid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: septic shock patient Exclusion Criteria: other causes of end-stage organ failure, immunodeficiency, presence of acute mesenteric ischemia, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic), life expectancy less than 48 hours corticosteroid use in the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hydrocortisone<br>The patients with septic shock who required a noradrenaline infusion rate above 0.5µg/kg | Drug: Drug Steroid<br>* hydrocortisone injection<br>* Other names: hydrocortisone;|
| control<br>The patients with septic shock who needed a noradrenaline infusion rate of up to 0.5µg/kg/min to maintain MAP>65 mmHg | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum angiotensin II levels | Serum angiotensin II levels | 0-3 days | 
| Serum angiotensin II reseptor 1 levels | Serum angiotensin II reseptor 1 levels | 0-3 days | 
| Serum angiotensin II reseptor 2 levels | Serum angiotensin II reseptor 2 levels | 0-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | mortality rate | 28 days | 
| SVRI | systemic vascular resistans index | 0-3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shock, Septic, hydrocortisone, angiotensin II