Prone Position and Renal Resistive Index (PRO-KIDNEY)

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 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.

Study Overview

• Status: Unknown
• Conditions: Acute Kidney Injury; Acute Respiratory Distress Syndrome; Intra-Abdominal Hypertension; Prone Position
• Intervention / Treatment: Other: Prone position

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Sophie Truche, M.D; Phone Number: + 33 476768779; Email: ASTruche@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prone position	Other: Prone position; Abdomen suspension in prone position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Acute kidney injury	According to creatinine or diuresis criteria of Kidney Disease: Improving Global Outcomes (K-DIGO) classification	within 48 hours following prone position

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: French Society for Intensive Care; Act For Chronic Diseases

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (ACTUAL): February 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Kidney Diseases; Urologic Diseases; Disease; Infant, Newborn, Diseases; Renal Insufficiency; Musculoskeletal Diseases; Muscular Diseases; Lung Injury; Infant, Premature, Diseases; Compartment Syndromes; Syndrome; Acute Kidney Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Intra-Abdominal Hypertension
• Other Study ID Numbers: 38RC19.265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No