CSI-RICU: 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)

Sponsor

University of Modena and Reggio Emilia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03897920

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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	Phase
Respiratory Failure Multi Organ Failure	Other: Doppler ultrasound assessment of renal arteria resistive index

Study Design

Study Type:

Observational

Anticipated 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)

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

Onset of shock [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Modena and Reggio Emilia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alessandro Marchioni, Principal Investigator, University of Modena and Reggio Emilia

ClinicalTrials.gov Identifier:

NCT03897920

Other Study ID Numbers:

UModenaReggio 6

First Posted:

Apr 1, 2019

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Multiple Organ Failure

Study Results

No Results Posted as of Mar 23, 2022