Acute Kidney InjuryRED-AKINCT06302192
Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)
An observational study of Acute Kidney Injury and ARDS, Human, run by Policlinico Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury, ARDS, Human
- What is being tested?
- ARDS+AKI
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV).
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
Official title: RED-AKI: Renal Doppler in Acute Kidney Injury. Capability of Intrarenal Venous Flow Doppler (IRVF) to Predict Acute Kidney Injury (AKI) in Critically Ill Patients With Acute Respiratory Distress Syndrome (ARDS)
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
- Being tested
- ARDS+AKI
- Keywords
- Renal Doppler
- Medical subject headings
- Acute Kidney Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARDS+AKIDiagnostic test
according to the clinical practice Reanl doppler and VeXUS score will be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence
Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group
Measured: 1st april 2024 - 31st of january 2026
Secondary outcomes (6)
AKI14
) Incidence of AKI within 14 days from the ARDS onset in patient with and without IRVF demodulated or with different IRVF pattern
Measured: 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
Measured: 1st april 2024 - 31st of january 2026
cross talk lung-kidney
invasive mechanical ventilation parameters (PEEP, Pressure of plateau, driving pressure and static compliance of the respiratory system) values and PaCO2 and PaO2/FiO2 values in the demodulated or in any IRVF pattern (continuous, pulsatility, biphasic and monophasic)
Measured: 1st april 2024 - 31st of january 2026
CRRT
IRVF pattern (continuous, pulsatility, biphasic, monophasic), VM, RIhil and RIintra, IRVFhil, SI and VexUS at the beginning and at the discontinuation of CRRT
Measured: 1st april 2024 - 31st of january 2026
incidence of failed exam
Percentage of exams successfully performed among the total of patients admitted to study
Measured: 1st april 2024 - 31st of january 2026
CKD progression
Incidence of CKD Incidence of CKD Cumulative Incidence of CKD
Measured: 1st april 2024 - 31st of january 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302192
- Sponsor's protocol ID
- 4302
- Acronym
- RED-AKI
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RED-AKI: Renal Doppler in Acute Kidney Injury. Capability of Intrarenal Venous Flow Doppler (IRVF) to Predict Acute Kidney Injury (AKI) in Critically Ill Patients With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT06302192
- Acronym / sponsor ID
- RED-AKI / 4302
- Conditions
- Acute Kidney Injury, ARDS, Human
- Keywords
- Renal Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARDS+AKIaccording to the clinical practice Reanl doppler and VeXUS score will be performed | Diagnostic test | – |
Primary outcome
cumulative incidence
Time frame: 1st april 2024 - 31st of january 2026
Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group
6 secondary outcomes
AKI14
Time frame: 1st april 2024 - 31st of january 2026
AKIstage
Time frame: 1st april 2024 - 31st of january 2026
cross talk lung-kidney
Time frame: 1st april 2024 - 31st of january 2026
CRRT
Time frame: 1st april 2024 - 31st of january 2026
incidence of failed exam
Time frame: 1st april 2024 - 31st of january 2026
CKD progression
Time frame: 1st april 2024 - 31st of january 2026
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and ARDS, Human, run by Policlinico Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence (time frame: 1st april 2024 - 31st of january 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.