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

Shock, Septic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647552
• Other study ID #: AOzer
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: February 6, 2021

Study information

• Verified date: February 2021
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 6, 2021
• Est. primary completion date: February 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Shock
• Shock, Septic

Intervention

Drug:
• Drug Steroid
hydrocortisone injection

Locations

Country	Name	City	State
Turkey	Ayse Belin B OZER	Malatya
Turkey	Ayse Belin OZER	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Zhang W, Chen X, Huang L, Lu N, Zhou L, Wu G, Chen Y. Severe sepsis: Low expression of the renin-angiotensin system is associated with poor prognosis. Exp Ther Med. 2014 May;7(5):1342-1348. Epub 2014 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum angiotensin II levels	Serum angiotensin II levels	0-3 days
Primary	Serum angiotensin II reseptor 1 levels	Serum angiotensin II reseptor 1 levels	0-3 days
Primary	Serum angiotensin II reseptor 2 levels	Serum angiotensin II reseptor 2 levels	0-3 days
Secondary	Mortality rate	mortality rate	28 days
Secondary	SVRI	systemic vascular resistans index	0-3 days