Acute Kidney InjuryR2D2NCT02355314
Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
A study testing Doppler-based renal and blood sample and urine sample in people with Acute Kidney Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial summary
Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria (oliguria and serum creatinine elevation), which carry several important limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Doppler-based renal and blood sample and urine sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2013to May 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sinus rhythm
- Use of conventional mechanical ventilation
Who cannot join
- Refusal: patient, family or trusted person to participate in the study
- Renal artery stenosis known
- Pregnant
- Severe Chronic Renal Failure (clearance < 30 ml.min-1)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Avicenne
Bobigny, 93000
CHU Gabriel Montpied
Clermont-Ferrand, 63000
CHU Saint-Louis
Paris, 75010
Chu de Saint Etienne
Saint-Etienne, 42000
CHRU de Strasbourg
Strasbourg, 67000
About this study
Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria (oliguria and serum creatinine elevation), which carry several important limitations. Additionally, the investigators lack biomarker that may predict short term renal prognosis.
Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative tool that may hold promise for early AKI detection in ICU patients or in differentiating transient from persistent AKI in selected critically ill patients. Although several studies have suggested adequate performance in predicting short-term reversibility of AKI, most of these studies were performed in limited patient samples. Additionally, a recent study has identified discrepant results regarding its diagnostic performance.
The main objective of this large prospective multicentre study is to assess diagnostic performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation.
- Conditions
- Acute Kidney Injury
- Being tested
- Doppler-based renal, blood sample and urine sample
- Keywords
- ICU patients, Doppler-based renal
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler-based renalOther
Doppler-based renal : day 0 and day 3
blood sample and urine sampleBiological
blood sample and urine sample : day 0 and day 3
| Study group | Role | What they receive |
|---|---|---|
| ICU patients requiring mechanical ventilation | Experimental | Not described Receives: Other: Doppler-based renal; Biological: blood sample and urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler-based renal resistive index
Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation
Measured: Day 0
Secondary outcomes (4)
Doppler-based renal resistive index
Measured: Day 3
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Measured: Day 0
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Measured: Day 3
usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startDec 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine LABRUYERE, Chef de projet, Study chair, URCIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355314
- Sponsor's protocol ID
- 1208184
- Other IDs
- ANSM
- Acronym
- R2D2
- Status last verified
- Sep 2016
- First submitted
- 22 Jan 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schnell D, Bourmaud A, Reynaud M, Rouleau S, Merdji H, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Darmon M. Performance of renal Doppler to predict the occurrence of acute kidney injury in patients without acute kidney injury at admission. J Crit Care. 2022 Jun;69:153983. doi: 10.1016/j.jcrc.2021.12.017. Epub 2022 Jan 21.
PubMed 35074631Saade A, Bourmaud A, Schnell D, Darmon M; R2D2 Study Group. Performance of Doppler-Based Resistive Index and Semiquantitative Renal Perfusion in Predicting Persistent Acute Kidney Injury According to Operator Experience: Post Hoc Analysis of a Prospective Multicenter Study. Crit Care Med. 2022 Apr 1;50(4):e361-e369. doi: 10.1097/CCM.0000000000005372.
PubMed 34678845Darmon M, Bourmaud A, Reynaud M, Rouleau S, Meziani F, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Schnell D. Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study. Intensive Care Med. 2018 Nov;44(11):1904-1913. doi: 10.1007/s00134-018-5386-3. Epub 2018 Oct 5.
PubMed 30291377
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
- ClinicalTrials.gov ID
- NCT02355314
- Acronym / sponsor ID
- R2D2 / 1208184
- Conditions
- Acute Kidney Injury
- Keywords
- ICU patients, Doppler-based renal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Feb 2015 (estimated)
- 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.
Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria (oliguria and serum creatinine elevation), which carry several important limitations. Additionally, the investigators lack biomarker that may predict short term renal prognosis.
Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative tool that may hold promise for early AKI detection in ICU patients or in differentiating transient from persistent AKI in selected critically ill patients. Although several studies have suggested adequate performance in predicting short-term reversibility of AKI, most of these studies were performed in limited patient samples. Additionally, a recent study has identified discrepant results regarding its diagnostic performance.
The main objective of this large prospective multicentre study is to assess diagnostic performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients requiring mechanical ventilation | Experimental | Other: Doppler-based renal, Biological: blood sample and urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sinus rhythm
- Use of conventional mechanical ventilation
Key exclusion criteria (4 listed)
- Refusal: patient, family or trusted person to participate in the study
- Renal artery stenosis known
- Pregnant
- Severe Chronic Renal Failure (clearance < 30 ml.min-1)
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 |
|---|---|---|
| Doppler-based renalDoppler-based renal : day 0 and day 3 | Other | ICU patients requiring mechanical ventilation |
| blood sample and urine sampleblood sample and urine sample : day 0 and day 3 | Biological | ICU patients requiring mechanical ventilation |
Primary outcome
Doppler-based renal resistive index
Time frame: Day 0
Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation
4 secondary outcomes
Doppler-based renal resistive index
Time frame: Day 3
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Time frame: Day 0
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Time frame: Day 3
usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Derived from this study: PubMed 35074631Schnell D, Bourmaud A, Reynaud M, Rouleau S, Merdji H, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Darmon M. Performance of renal Doppler to predict the occurrence of acute kidney injury in patients without acute kidney injury at admission. J Crit Care. 2022 Jun;69:153983. doi: 10.1016/j.jcrc.2021.12.017. Epub 2022 Jan 21.
- Derived from this study: PubMed 34678845Saade A, Bourmaud A, Schnell D, Darmon M; R2D2 Study Group. Performance of Doppler-Based Resistive Index and Semiquantitative Renal Perfusion in Predicting Persistent Acute Kidney Injury According to Operator Experience: Post Hoc Analysis of a Prospective Multicenter Study. Crit Care Med. 2022 Apr 1;50(4):e361-e369. doi: 10.1097/CCM.0000000000005372.
- Derived from this study: PubMed 30291377Darmon M, Bourmaud A, Reynaud M, Rouleau S, Meziani F, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Schnell D. Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study. Intensive Care Med. 2018 Nov;44(11):1904-1913. doi: 10.1007/s00134-018-5386-3. Epub 2018 Oct 5.
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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.
Carine LABRUYERE, Chef de projet study chair
URCIP
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler-based renal and blood sample and urine sample in people with Acute Kidney Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Doppler-based renal resistive index (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355314, which also lists 3 linked publications.
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 20 Sep 2016.