Prone Position and Renal Resistive Index

Acute Kidney Injury Clinical Trial

— PRO-KIDNEY  

Official title:

Effect of Prone Position on Renal Resistive Index Among Patients With Acute Respiratory Distress Syndrome. The Role of Intra-abdominal Pressure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04286490
• Other study ID #: 38RC19.265
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: June 2022

Study information

• Verified date: May 2020
• Source: University Hospital, Grenoble
• Contact: Anne-Sophie Truche, M.D
• Phone: + 33 476768779
• Email: ASTruche[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 29
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ARDS patients according to Berlin criteria, intubated, mechanically ventilated since at least 24 hours,

• 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

Exclusion Criteria:

• 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

• cardiac arrhythmia

• obesity

• advanced cirrhosis

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Intra-Abdominal Hypertension
• Prone Position
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• Prone position
Abdomen suspension in prone position

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Act For Chronic Diseases, French Society for Intensive Care

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary	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	At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary	change in cell-cycle arrest biomarkers	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	At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary	ventilatory mechanics: transpulmonary pressure	transpulmonary pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger	At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary	ventilatory mechanics: driving pressure	driving pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger	At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary	ventilatory mechanics: elastance	elastance will be measured at the end of inspiration and expiration and continuously recorded on a datalogger	At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary	haematosis	arterial oxygen tension (PaO2) and arterial dioxide carbon tension (PaC02)	At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary	Intra abdominal pressure	Intra abdominal pressure will be measured thanks to a dedicated nasogastric tube with two balloons (gastric 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
Secondary	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).	Two hours after patients are back in supine position
Secondary	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	Two hours after patients are back in supine position
Secondary	Persisting effect of IAP increase in prone position when patients are back in supine position on cell-cycle arrest biomarkers	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	Two hours after patients are back in supine position
Secondary	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	Two hours after patients are back in supine position
Secondary	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	Two hours after patients are back in supine position
Secondary	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	Two hours after patients are back in supine position
Secondary	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)	Two hours after patients are back in supine position
Secondary	Acute kidney injury	According to creatinine or diuresis criteria of Kidney Disease: Improving Global Outcomes (K-DIGO) classification	within 48 hours following prone position