Acute Respiratory Distress SyndromePRO-KIDNEYNCT04286490
Prone Position and Renal Resistive Index
A study testing Prone position in people with Acute Respiratory Distress Syndrome and Acute Kidney Injury, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Patients suffering from Acute Respiratory Distress Syndrome (ARDS) with a prone position (PP) indication will benefit from measurements of renal resistive index, intra-abdominal pressure (IAP), urinary oxygen tension (uPO2) and ventilatory mechanics in supine position (baseline IAP), after 2 hours in PP at the current… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Kidney Injury, Prone Position
- What is being tested?
- Prone position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to 30 Jun 2022
- 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
- ARDS patients according to Berlin criteria, intubated, mechanically ventilated
- with PaO₂/FiO₂ < 150 mmHg,
- neuromuscular blockade
- with an indication of PP done by the physician in charge
- possibility to differ PP for one hour
- patients should be hemodynamically stable since at least 4 hours
Who cannot join
- Pregnant or breast-feeding women
- legal protection, no social security affiliation
- PP contra-indication
- nasogastric tube contra-indication
- extra corporeal membrane oxygenation
- acute kidney injury at inclusion according to K-DIO criteria, chronic kidney disease defined as an estimated glomerualr filtration rate less than 30 ml/min/1.73m², kidney transplantation, renal artery stenosis, solitary kidney, albuminuria > 1.25 mg/ml
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- cardiac arrhythmia
- obesity
- advanced cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prone Position on Renal Resistive Index Among Patients With Acute Respiratory Distress Syndrome. The Role of Intra-abdominal Pressure
Patients suffering from Acute Respiratory Distress Syndrome (ARDS) with a prone position (PP) indication will benefit from measurements of renal resistive index, intra-abdominal pressure (IAP), urinary oxygen tension (uPO2) and ventilatory mechanics in supine position (baseline IAP), after 2 hours in PP at the current IAP value, thirty minutes after patients' abdomen suspension in order to resume baseline IAP and after patients' are turned back to supine position.
- Conditions
- Acute Respiratory Distress Syndrome, Acute Kidney Injury, Prone Position, Intra-Abdominal Hypertension
- Being tested
- Prone position
- Medical subject headings
- Respiratory Distress Syndrome, Acute Kidney Injury, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
Abdomen suspension in prone position
| Study group | Role | What they receive |
|---|---|---|
| Prone position | Experimental | Not described Receives: Other: Prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in renal resistive index (RRI)
RRI measurement will be performed on a right kidney arcuate/interlobar artery, with a high frequency Doppler probe. Three to five consecutive measures will be obtained then RRI computed according to the formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity).
Measured: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary outcomes (13)
change in renal medullary oxygen tension
urinary oxygen tension (uPO₂) will be measured via a fiber-optic luminescence optode inserted through the bladder catheter lumen
Measured: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: transpulmonary pressure
transpulmonary pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
Measured: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: driving pressure
driving pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
Measured: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: elastance
elastance will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
Measured: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
haematosis
arterial oxygen tension (PaO2) and arterial dioxide carbon tension (PaC02)
Measured: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Intra abdominal pressure
Intra abdominal pressure will be measured thanks to a dedicated nasogastric tube with two balloons (gastric pressure)
Measured: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver and two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on renal resistive index
RRI measurement will be performed on a right kidney arcuate/interlobar artery, with a high frequency Doppler probe. Three to five consecutive measures will be obtained then RRI computed according to the formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity).
Measured: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on urinary PO2
urinary oxygen tension (uPO₂) will be measured via a fiber-optic luminescence optode inserted through the bladder catheter lumen
Measured: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: transpulmonary pressure
transpulmonary pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
Measured: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: driving pressure
driving pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
Measured: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: elastance
elastance will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
Measured: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on haematosis
arterial oxygen tension (PaO2) and arterial dioxide carbon tension (PaC02)
Measured: Two hours after patients are back in supine position
Acute kidney injury
According to creatinine or diuresis criteria of Kidney Disease: Improving Global Outcomes (K-DIGO) classification
Measured: within 48 hours following prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start30 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- French Society for Intensive Care, Act For Chronic Diseases
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286490
- Sponsor's protocol ID
- 38RC19.265
- Acronym
- PRO-KIDNEY
- Status last verified
- Jan 2025
- First submitted
- 18 Feb 2020
- Last updated
- 29 Jan 2025
- 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 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prone Position on Renal Resistive Index Among Patients With Acute Respiratory Distress Syndrome. The Role of Intra-abdominal Pressure
- ClinicalTrials.gov ID
- NCT04286490
- Acronym / sponsor ID
- PRO-KIDNEY / 38RC19.265
- Conditions
- Acute Respiratory Distress Syndrome, Acute Kidney Injury, Prone Position, Intra-Abdominal Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- French Society for Intensive Care, Act For Chronic Diseases
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Feb 2020 (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.
Patients suffering from Acute Respiratory Distress Syndrome (ARDS) with a prone position (PP) indication will benefit from measurements of renal resistive index, intra-abdominal pressure (IAP), urinary oxygen tension (uPO2) and ventilatory mechanics in supine position (baseline IAP), after 2 hours in PP at the current IAP value, thirty minutes after patients' abdomen suspension in order to resume baseline IAP and after patients' are turned back to supine position.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prone position | Experimental | Other: Prone position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ARDS patients according to Berlin criteria, intubated, mechanically ventilated
- with PaO₂/FiO₂ < 150 mmHg,
- neuromuscular blockade
- with an indication of PP done by the physician in charge
- possibility to differ PP for one hour
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding women
- legal protection, no social security affiliation
- PP contra-indication
- nasogastric tube contra-indication
- extra corporeal membrane oxygenation
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 |
|---|---|---|
| Prone positionAbdomen suspension in prone position | Other | Prone position |
Primary outcome
change in renal resistive index (RRI)
Time frame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
RRI measurement will be performed on a right kidney arcuate/interlobar artery, with a high frequency Doppler probe. Three to five consecutive measures will be obtained then RRI computed according to the formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity).
13 secondary outcomes
change in renal medullary oxygen tension
Time frame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: transpulmonary pressure
Time frame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: driving pressure
Time frame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: elastance
Time frame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
haematosis
Time frame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Intra abdominal pressure
Time frame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver and two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on renal resistive index
Time frame: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on urinary PO2
Time frame: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: transpulmonary pressure
Time frame: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: driving pressure
Time frame: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: elastance
Time frame: Two hours after patients are back in supine position
Persisting effect of IAP increase in prone position when patients are back in supine position on haematosis
Time frame: Two hours after patients are back in supine position
Acute kidney injury
Time frame: within 48 hours following prone position
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 29 Jan 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position in people with Acute Respiratory Distress Syndrome and Acute Kidney Injury, run by University Hospital, Grenoble at 1 site 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 6 inclusion and 9 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
change in renal resistive index (RRI) (time frame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver). 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 29 Jan 2025.