- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897920
Doppler Ultrasound Renal Arterial Resistive Indices As Predictor Of Multiorgan Failure In Patients With Acute Hypoxic Respiratory Failure Admitted To Respiratory Intensive Care Unit (Cryptic Shock Index- RICU) (CSI-RICU)
March 21, 2022 updated by: Alessandro Marchioni, University of Modena and Reggio Emilia
Doppler Ultrasound Renal Arterial Resistive Indices As Predictor Of Multiorgan Failure In Patients With Acute Hypoxic Respiratory Failure Admitted To Respiratory Intensive Care Unit (Cryptic Shock Index CSI- RICU)
Patients with de novo respiratory failure undergoing non invasive ventilation (NIV) present failure rates of mechanical ventilation ranging from 4 to 50%.
Causes for NIV treatment failure are various but the onset of septic shock and subsequent multi-organ failure (MOF) seem play a critical role.
Recent data show that the 37% of patients admitted to intensive care unit for de novo respiratory failure without any other organ failure experience multiple organ failure within the first days from admission.
Early identification of hypoxic patients at major risk for MOF seems critical.
Physiological studies have demonstrated that the underlying mechanisms for organ damage preceding MOF are those involved in the oxygen consumption (VO2)/oxygen delivery (DO2) mismatch.
Doppler ultrasound indices of renal arteria resistance are directly correlated tot he VO2/DO2 mismatch.
With this study we aim at investigating the correlation between Doppler ultrasound indices of renal arteria resistance in patients with de novo respiratory failure admitted to ICU and the onset of MOF within the first 7 days form admission.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alessandro Marchioni, MD
- Phone Number: 00390594225859
- Email: marchioni.alessandro@unimore.it
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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with de novo respiratory failure admitted to the respiratory intensive care unit of the university hospital of Modena without any other organ failure
Description
Inclusion Criteria:
- patients with de novo respiratory failure admitted to the respiratory intensive care unit of the university hospital of Modena
Exclusion Criteria:
- age lower than 18 or higher than 85
- presence of organ failure apart form lung failure at the time of admission in the respiratory intensive care unit
- pregnancy
- difficult or unreliable ultrasound window for renal arterial resistive index assessment
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset of shock
Time Frame: 7 days from Respiratory Intensive Care Unit admission
|
Shock will be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia
|
7 days from Respiratory Intensive Care Unit admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
January 1, 2024
Study Completion (Anticipated)
January 1, 2025
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
March 29, 2019
First Posted (Actual)
April 1, 2019
Study Record Updates
Last Update Posted (Actual)
March 23, 2022
Last Update Submitted That Met QC Criteria
March 21, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UModenaReggio 6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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