- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06214715
Renal Resistive Index in Septic Shock Patients
January 23, 2024 updated by: Bezmialem Vakif University
Renal Resistive Index and Tissue Hypoperfusion Parameters and Prognosis Relationship in Septic Shock Patients
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
After initial hemodynamic stabilization is achieved, RRI will be calculated by renal ultrasonography within 24 hours.
Simultaneously with renal ultrasonography, blood samples will be taken from arterial and central venous catheters, partial arterial oxygen pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2), partial central venous oxygen pressure (PcvO2) and partial central venous carbon dioxide pressure (PcvCO2), arterial Oxygen saturation (SaO2), central venous oxygen saturation (ScvO2), hemoglobin concentration and arterial lactate levels will be recorded.
An attempt will be made to gain an idea about the course of the disease by comparing RRI with these global tissue hypoperfusion parameters.
Study Type
Observational
Enrollment (Actual)
50
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
-
-
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Istanbul, Turkey, 34000
- Bezmialem Vakıf University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-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.
Description
Inclusion Criteria:
- Followed up due to sepsis
- In need of intensive care follow-up
- In need of invasive mechanical ventilation
- Sofa score >2
Exclusion Criteria:
- 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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal resistive index
Time Frame: 24 hour
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Monira Rahim, M.D., Bezmialem Vakif University
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)
October 20, 2023
Primary Completion (Estimated)
January 30, 2024
Study Completion (Estimated)
December 2, 2024
Study Registration Dates
First Submitted
January 10, 2024
First Submitted That Met QC Criteria
January 10, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Estimated)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BVU-AR-MR-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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