SepsisNCT04716842
Evaluation of Plasma Angiotensin II and Angiotensin II Receptor Levels in Patients With Sepsis and Septic Shock: a Prospective Observational Study.
An observational study of Sepsis and Septic Shock, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of plasma angiotensin II and angiotensin II receptor levels in patients with sepsis and septic shock: a prospective observational study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- intensive care unit patient
Who cannot join
- End-stage organ failure,
- immunodeficiency, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic) a life expectancy of less than 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, angiotensin II
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
angiotensin II levels
serum angiotensin II levels
Measured: 0-3 days
angiotensin II receptor I
serum angiotensin II receptor I levels
Measured: 0-3 days
angiotensin II receptor II
serum angiotensin II receptor II levels
Measured: 0-3 days
Secondary outcomes (3)
procalsitonine level
Procalsitonine level
Measured: 0-3 days
crp level
crp levels
Measured: 0-3 days
mortality
mortality rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Jan 2021
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Belin Ozer, Inonu University
- Investigators
- Ayse Belin B OZER, Principal investigator, Inonu University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716842
- Sponsor's protocol ID
- AOzer2
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma Angiotensin II and Angiotensin II Receptor Levels in Patients With Sepsis and Septic Shock: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT04716842
- Acronym / sponsor ID
- AOzer2
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, angiotensin II
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of plasma angiotensin II and angiotensin II receptor levels in patients with sepsis and septic shock: a prospective observational study.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- intensive care unit patient
Key exclusion criteria (2 listed)
- End-stage organ failure,
- immunodeficiency, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic) a life expectancy of less than 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
angiotensin II levels
Time frame: 0-3 days
serum angiotensin II levels
angiotensin II receptor I
Time frame: 0-3 days
serum angiotensin II receptor I levels
angiotensin II receptor II
Time frame: 0-3 days
serum angiotensin II receptor II levels
3 secondary outcomes
procalsitonine level
Time frame: 0-3 days
crp level
Time frame: 0-3 days
mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Belin B OZER principal investigator
Inonu University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
angiotensin II levels (time frame: 0-3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.