Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)

NCT ID: NCT06302192

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-06-30

Brief Summary

This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:

• PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset
• SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation

Conditions

Acute Kidney Injury; ARDS, Human

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

ARDS+AKI

according to the clinical practice Reanl doppler and VeXUS score will be performed

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Critically ill patients admitted to intensive care unit with a diagnosis of ARDS according to Berlino criteria
• Beginning of IMV less than 48 hours or Clinical decision to begin IMV.
• Life expectancy > 24 hours
• Informed consent signed

Exclusion Criteria

No patient will be excluded from the study because of gender, race, ethnicity, or sexual preference.

• AKI prior to the onset of ARDS
• Chronic respiratory failure due to chronic respiratory diseases
• Chronic renal disease (CKD stage ≥ 2) and any ureteral obstruction. Definition of CKD patient is according to the latest guideline KDIGO
• Chronic Heart Failure
• Chronic liver disease
• Major trauma in the past 3 months
• Major surgery in the past 3 months
• Smoking and Alcohol drinking
• BMI ≥ 35
• Patients needing of VV-ECMO and VA-ECMO
• Beginning of positive pressure ventilation more than 48 hours (invasive or no invasive)
• Life expectancy <24 hours
• Cardio Circulatory Arrest
• Neoplasm in chemotherapy/radiotherapy
• Do Not Resuscitate or Comfort Measures
• Pregnancy at ICU admission
• Refused Informed Consent by the patient or surrogate decision-maker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Policlinico Hospital

OTHER

Sponsor Role: lead

Responsible Party

Giacomo Grasselli

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

4302

Identifier Type: -

Identifier Source: org_study_id