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NCT Number: NCT04647552

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

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.

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Key information

Conditions

Shock, Septic Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ayse Belin B OZER, Malatya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Steroid

Drug

hydrocortisone injection

Other names: hydrocortisone

Primary outcomes

  1. Serum angiotensin II levels

    Time frame: 0-3 days

    Serum angiotensin II levels

  2. Serum angiotensin II reseptor 1 levels

    Time frame: 0-3 days

    Serum angiotensin II reseptor 1 levels

  3. Serum angiotensin II reseptor 2 levels

    Time frame: 0-3 days

    Serum angiotensin II reseptor 2 levels

Secondary outcomes

  1. Mortality rate

    Time frame: 28 days

    mortality rate

  2. SVRI

    Time frame: 0-3 days

    systemic vascular resistans index

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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