Evaluation of Plasma Angiotensin II and Angiotensin II Receptor Levels in Patients With Sepsis and Septic Shock: a Prospective Observational Study.

NCT04716842 | Unknown

• 1 other identifier: AOzer2
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of plasma angiotensin II and angiotensin II receptor levels in patients with sepsis and septic shock: a prospective observational study.

Conditions

Sepsis; Septic Shock

Keywords

sepsis; septic shock; angiotensin II

Outcome Measures

Primary Outcomes (3)

• angiotensin II levels

  serum angiotensin II levels

  0-3 days

• angiotensin II receptor I

  serum angiotensin II receptor I levels

  0-3 days

• angiotensin II receptor II

  serum angiotensin II receptor II levels

  0-3 days

Secondary Outcomes (3)

• procalsitonine level

  0-3 days

• crp level

  0-3 days

• mortality

  28 days

Study Arms (3)

sepsis

In intensive care patients with suspected or proven infection, if the SOFA score ≥2, the patients will be evaluated as sepsis and routine examination, monitoring and treatment will be applied.

septic shock

Patients with sepsis who require vasopressor to keep mean arterial pressure above 65 mmHg and lactate\> 2 mmol/l will be included in the septic shock group.

control

It will be formed from patients who are hospitalized in the intensive care unit for a reason other than sepsis and septic shock, without suspected or proven infection.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group sepsis (n = 25): In intensive care patients with suspected or proven infection, if the SOFA score ≥2, the patients will be evaluated as sepsis and routine examination, monitoring and treatment will be applied. Group septic shock (n = 25): Patients with sepsis who require vasopressor to keep mean arterial pressure above 65 mmHg and lactate\> 2 mmol/l will be included in the septic shock group. Group Control (n = 25): It will be formed from patients who are hospitalized in the intensive care unit for a reason other than sepsis and septic shock, without suspected or proven infection.

You may qualify if:

• intensive care unit patient

You may not qualify if:

• End-stage organ failure,
• immunodeficiency, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic) a life expectancy of less than 48 hours

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Ayse Belin B OZER

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayse Belin B OZER

  Inonu University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 20, 2021
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

TU (1)