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

Completed

• Conditions: Shock, Septic
• Interventions: Drug: Drug Steroid

• Registration Number: NCT04647552
• Lead Sponsor: Inonu University

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.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Status Verified: 2021-02
• Primary Completion: 2021-02-06
• Study Completion: 2021-02-06
• Last Update Submitted: 2021-02-06
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hydrocortisone	Drug Steroid	The patients with septic shock who required a noradrenaline infusion rate above 0.5µg/kg

Primary Outcome Measures

Name	Time	Method
Serum angiotensin II reseptor 2 levels	0-3 days	Serum angiotensin II reseptor 2 levels
Serum angiotensin II levels	0-3 days	Serum angiotensin II levels
Serum angiotensin II reseptor 1 levels	0-3 days	Serum angiotensin II reseptor 1 levels

Secondary Outcome Measures

Name	Time	Method
Mortality rate	28 days	mortality rate
SVRI	0-3 days	systemic vascular resistans index

Trial Locations

Locations (2)

Ayse Belin B OZER; 🇹🇷 Malatya, Turkey

Ayse Belin OZER; 🇹🇷 Malatya, Turkey