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

NCT06302192 | Not Yet Recruiting

• 1 other identifier: 4302
• Study Type: observational
• Target: 164
• Locations: 0 countries
• Sites: N/A

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

Keywords

Renal Doppler

Outcome Measures

Primary Outcomes (1)

• cumulative incidence

  Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group

  1st april 2024 - 31st of january 2026

Secondary Outcomes (6)

• AKI14

  1st april 2024 - 31st of january 2026

• AKIstage

  1st april 2024 - 31st of january 2026

• cross talk lung-kidney

  1st april 2024 - 31st of january 2026

• CRRT

  1st april 2024 - 31st of january 2026

• incidence of failed exam

  1st april 2024 - 31st of january 2026

Interventions

ARDS+AKI DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Policlinico Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

on day #1, on day #3, on day #7 and on day #14 any 3 ml of urine and 3 ml of blood will be stocked

MeSH Terms

Conditions

Acute Kidney Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 8, 2024

Record last verified: 2024-03