CClinicalTrials.gg
Status unknownNCT04716842Updated Jan 20, 2021

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

An observational study in Sepsis and Septic Shock, sponsored by Inonu University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-20.

Sponsored by Inonu University · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Sepsis
  • Septic Shock

Keywords

  • sepsis
  • septic shock
  • angiotensin II
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 75 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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.

Inclusion criteria

  • intensive care unit patient

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. angiotensin II levels

    serum angiotensin II levels

    Time frame: 0-3 days

  2. angiotensin II receptor I

    serum angiotensin II receptor I levels

    Time frame: 0-3 days

  3. angiotensin II receptor II

    serum angiotensin II receptor II levels

    Time frame: 0-3 days

Secondary outcomes

  1. procalsitonine level

    Procalsitonine level

    Time frame: 0-3 days

  2. crp level

    crp levels

    Time frame: 0-3 days

  3. mortality

    mortality rate

    Time frame: 28 days

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Study locations

1 site
  • Ayse Belin B OZER
    Malatya, Turkey
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04716842
Lead sponsor
Inonu University
Responsible party
Ayse Belin Ozer (Prof. Dr., Inonu University) — Principal investigator
First posted
Jan 20, 2021
Start date
Jan 1, 2021
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Jan 20, 2021

Study contacts

Ayse Belin B OZER
principal investigator · Inonu University Faculty of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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