Renal Doppler to Predict Acute Kidney Injury (AKI) in ARD... | NCT06302192

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

NCT06302192

Sponsor

Policlinico Hospital

Status

Unknown status

Last Update Posted

Mar 8, 2024Actual

Enrollment

164Estimated

Phase

Not provided

Conditions

Acute Kidney Injury
ARDS, Human

Interventions

ARDS+AKI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Jan 31, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Mar 4, 2024

First Submission Date that Met QC Criteria

Mar 4, 2024

First Posted Date

Mar 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2024

Last Update Posted Date

Mar 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

164Estimated

Name	Type	Description	Arm Group Labels	Other Names
ARDS+AKI	Diagnostic Test	according to the clinical practice Reanl doppler and VeXUS score will be performed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
AKI14	) Incidence of AKI within 14 days from the ARDS onset in patient with and without IRVF demodulated or with different IRVF pattern	1st april 2024 - 31st of january 2026
AKIstage	VM, RIhil and RIintra, SI, VexUS values in AKI and no AKI patients and in the different AKI stage

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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Browse Branches

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