NCT06214715

Brief Summary

Septic shock is a condition of acute circulatory failure and is defined as a process that requires the use of vasopressors to ensure adequate tissue perfusion when hypotension develops. It is mainly characterized by abnormal peripheral vascular resistance; Therefore, improving vascular function and organ damage is crucial in the management of septic shock. Blood flow measurement with Doppler-based renal resistive index (RRI), which can be performed at the bedside, especially in renal abnormalities, is currently accepted as a tool to assess renal perfusion. With this simple, rapid and reproducible technique, the investigators determine RRI by evaluating systolic and diastolic blood velocity from Doppler flow waveforms in the intrarenal arcuate or interlobar arteries. Our aim is to investigate the relationship between renal resistive index (RRI) and global tissue hypoperfusion parameters and clinical outcomes in septic shock patients admitted to the intensive care unit and receiving invasive mechanical ventilator support.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

January 10, 2024

Last Update Submit

January 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Renal resistive index

    The renal arterial resistive index (RI) is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70

    24 hour

Interventions

RRI will be measured by renal ultrasonography with a C5-1 convex probe using a Philips ultrasonography model device.

Eligibility Criteria

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

It is planned for patients who are admitted due to septic shock and need invasive mechanical ventilator support, who have a central venous catheter inserted for central venous pressure measurement and advanced monitoring, and who have undergone invasive arterial monitoring for close hemodynamic monitoring.

You may qualify if:

  • Followed up due to sepsis
  • In need of intensive care follow-up
  • In need of invasive mechanical ventilation
  • Sofa score \>2

You may not qualify if:

  • Hypothermic patients (\<35C)
  • with chronic renal failure
  • Pregnant women
  • Those with renal artery stenosis
  • Structural kidney damage
  • Patient with previous renal surgery
  • Intra-abdominal postoperative surgery patients
  • Patients with atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Monira Rahim, M.D.

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 22, 2024

Study Start

October 20, 2023

Primary Completion

January 30, 2024

Study Completion

December 2, 2024

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations