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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)

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ClinicalTrials.gov Identifier: NCT03897920
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Alessandro Marchioni, University of Modena and Reggio Emilia

Brief Summary:
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.

Condition or disease Intervention/treatment
Respiratory Failure Multi Organ Failure Other: Doppler ultrasound assessment of renal arteria resistive index

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Doppler ultrasound assessment of renal arteria resistive index
    A high frequency probe will be used together with the use of color or power Doppler to help vessel localization. As resistance to blood flow progressively increases from the hilar arteries toward the more peripheral parenchymal vessels, renal arteria resistive index (RRI) will be done at the level of the arcuate or interlobar arteries, adjacent to medullary pyramids. Measurements will be repeated in different parts of both organs (superior, median, and lower) when at least three reproducible waveforms have been obtained. An RRI will be calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and the mean value of three measurements at each kidney is usually considered. An RRI value 0.60 ± 0.01 (mean ± SD) is usually taken as normal with a value of 0.70 being considered the upper normal threshold


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897920


Contacts
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Contact: Alessandro Marchioni, MD 00390594225859 marchioni.alessandro@unimore.it

Sponsors and Collaborators
University of Modena and Reggio Emilia

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Responsible Party: Alessandro Marchioni, Principal Investigator, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT03897920    
Other Study ID Numbers: UModenaReggio 6
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Multiple Organ Failure
Respiration Disorders
Respiratory Tract Diseases
Shock
Pathologic Processes