NCT04647552

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

November 23, 2020

Last Update Submit

February 6, 2021

Conditions

Shock, Septic

Keywords

Shock, Septichydrocortisoneangiotensin II

Outcome Measures

Primary Outcomes (3)

  • Serum angiotensin II levels

    Serum angiotensin II levels

    0-3 days

  • Serum angiotensin II reseptor 1 levels

    Serum angiotensin II reseptor 1 levels

    0-3 days

  • Serum angiotensin II reseptor 2 levels

    Serum angiotensin II reseptor 2 levels

    0-3 days

Secondary Outcomes (2)

  • Mortality rate

    28 days

  • SVRI

    0-3 days

Study Arms (2)

hydrocortisone

The patients with septic shock who required a noradrenaline infusion rate above 0.5µg/kg

Drug: Drug Steroid

control

The patients with septic shock who needed a noradrenaline infusion rate of up to 0.5µg/kg/min to maintain MAP\>65 mmHg

Interventions

Drug SteroidDRUG

hydrocortisone injection

Also known as: hydrocortisone
hydrocortisone

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study was enrolled 40 patients diagnosed with septic shock according to Sepsis 3 criteria.

You may qualify if:

  • septic shock patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ayse Belin B OZER

Malatya, Turkey (Türkiye)

Location

Ayse Belin OZER

Malatya, Turkey (Türkiye)

Location

Related Publications (2)

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PMID: 26903338BACKGROUND

  • Zhang W, Chen X, Huang L, Lu N, Zhou L, Wu G, Chen Y. Severe sepsis: Low expression of the renin-angiotensin system is associated with poor prognosis. Exp Ther Med. 2014 May;7(5):1342-1348. doi: 10.3892/etm.2014.1566. Epub 2014 Feb 20.

    PMID: 24940436BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Shock, Septic

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Ayse Belin B OZER

    Inonu University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

November 1, 2020

Primary Completion

February 6, 2021

Study Completion

February 6, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

TU(2)