PRO-KIDNEY: Prone Position and Renal Resistive Index
Study Details
Study Description
Brief Summary
Patients suffering from Acute Respiratory Distress Syndrome (ARDS) with a prone position (PP) indication will benefit from measurements of radiological and biological kidney injury markers, intra-abdominal pressure (IAP) 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prone position
|
Other: Prone position
Abdomen suspension in prone position
|
Outcome Measures
Primary Outcome Measures
- change in renal resistive index (RRI) [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).
Secondary Outcome Measures
- change in renal medullary oxygen tension [At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver]
urinary oxygen tension (uPO₂) will be measured via a fiber-optic luminescence optode inserted through the bladder catheter lumen
- change in cell-cycle arrest biomarkers [At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver]
Tissue inhibitor of metalloproteinases 2 and Insulin-like growth factor-binding protein 7 concentrations product ([TIMP2] · [IGFBP7]) will be measured with a sandwich immunoassay technique
- ventilatory mechanics: transpulmonary pressure [At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver]
transpulmonary pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
- ventilatory mechanics: driving pressure [At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver]
driving pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
- ventilatory mechanics: elastance [At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver]
elastance will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
- haematosis [At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver]
arterial oxygen tension (PaO2) and arterial dioxide carbon tension (PaC02)
- Intra abdominal pressure [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]
Intra abdominal pressure will be measured thanks to a dedicated nasogastric tube with two balloons (gastric pressure)
- Persisting effect of IAP increase in prone position when patients are back in supine position on renal resistive index [Two hours after patients are back in supine position]
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).
- Persisting effect of IAP increase in prone position when patients are back in supine position on urinary PO2 [Two hours after patients are back in supine position]
urinary oxygen tension (uPO₂) will be measured via a fiber-optic luminescence optode inserted through the bladder catheter lumen
- Persisting effect of IAP increase in prone position when patients are back in supine position on cell-cycle arrest biomarkers [Two hours after patients are back in supine position]
Tissue inhibitor of metalloproteinases 2 and Insulin-like growth factor-binding protein 7 concentrations product ([TIMP2] · [IGFBP7]) will be measured with a sandwich immunoassay technique
- Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: transpulmonary pressure [Two hours after patients are back in supine position]
transpulmonary pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
- Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: driving pressure [Two hours after patients are back in supine position]
driving pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
- Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: elastance [Two hours after patients are back in supine position]
elastance will be measured at the end of inspiration and expiration and continuously recorded on a datalogger
- Persisting effect of IAP increase in prone position when patients are back in supine position on haematosis [Two hours after patients are back in supine position]
arterial oxygen tension (PaO2) and arterial dioxide carbon tension (PaC02)
- Acute kidney injury [within 48 hours following prone position]
According to creatinine or diuresis criteria of Kidney Disease: Improving Global Outcomes (K-DIGO) classification
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ARDS patients according to Berlin criteria, intubated, mechanically ventilated since at least 24 hours,
-
with PaO₂/FiO₂ < 150 mmHg,
-
neuromuscular blockade
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with an indication of PP done by the physician in charge
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possibility to differ PP for one hour
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patients should be hemodynamically stable since at least 4 hours
Exclusion Criteria:
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Pregnant or breast-feeding women
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legal protection, no social security affiliation
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PP contra-indication
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nasogastric tube contra-indication
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extra corporeal membrane oxygenation
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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
-
cardiac arrhythmia
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obesity
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advanced cirrhosis
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Grenoble
- French Society for Intensive Care
- Act For Chronic Diseases
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 38RC19.265