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

January 16, 2021 updated by: Ayse Belin Ozer, Inonu University
Evaluation of plasma angiotensin II and angiotensin II receptor levels in patients with sepsis and septic shock: a prospective observational study.

Study Overview

Status

Unknown

Conditions

Detailed Description

There is an increasing number of experimental publications investigated effects of angiotensin II and receptors on the pathogenesis and treatment of sepsis and septic shock. However, its level in humans and its relationship with the severity of the disease has not been investigated. If angiotensin II plays a role in the diagnosis and prognosis of septic shock by evaluating this relationship in our study, it may be a biomarker to be used in future diagnosis, prediction of prognosis and treatment. This will enable early recognition and treatment of this disease, which causes high mortality and cost in intensive care units, thus increasing the survival rate and reducing the cost.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey
        • Ayse Belin B OZER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • intensive care unit patient

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiotensin II levels
Time Frame: 0-3 days
serum angiotensin II levels
0-3 days
angiotensin II receptor I
Time Frame: 0-3 days
serum angiotensin II receptor I levels
0-3 days
angiotensin II receptor II
Time Frame: 0-3 days
serum angiotensin II receptor II levels
0-3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procalsitonine level
Time Frame: 0-3 days
Procalsitonine level
0-3 days
crp level
Time Frame: 0-3 days
crp levels
0-3 days
mortality
Time Frame: 28 days
mortality rate
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Principal Investigator: Ayse Belin B OZER, Inonu University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

January 16, 2021

First Submitted That Met QC Criteria

January 16, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOzer2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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