Clinical trial NCT04647552: Effects of Hydrocortison Treatment on Angiotensin II and Angiotensin II Receptors in Patients With Septic Shock
Official title: The Effect of Hydrocortison Treatment on Angiotensin II and Angiotensin Receptors in Patients Suffering From Septic Shock: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock, Septic
Keywords: Shock, Septic
hydrocortisone
angiotensin II
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was enrolled 40 patients diagnosed with septic shock according to Sepsis 3 criteria.

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.

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

Primary outcomes:
measure: Serum angiotensin II levels
timeFrame: 0-3 days
measure: Serum angiotensin II reseptor 1 levels
timeFrame: 0-3 days
measure: Serum angiotensin II reseptor 2 levels
timeFrame: 0-3 days
Secondary outcomes:
measure: Mortality rate
timeFrame: 28 days
measure: SVRI
timeFrame: 0-3 days
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Ayse Belin B OZER
city: Malatya
country: Turkey
facility: Ayse Belin OZER
Study officials:
affiliation: Inonu University Faculty of Medicine
name: Ayse Belin B OZER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.3892/etm.2014.1566. Epub 2014 Feb 20.