Clinical trial NCT04286490: Prone Position and Renal Resistive Index
Official title: Effect of Prone Position on Renal Resistive Index Among Patients With Acute Respiratory Distress Syndrome. The Role of Intra-abdominal Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Acute Kidney Injury
Prone Position
Intra-Abdominal Hypertension
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: French Society for Intensive Care
name: Act For Chronic Diseases
First posted: 2020-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 IAP value, thirty minutes after patients' abdomen suspension in order to resume baseline IAP and after patients' are turned back to supine position.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: change in renal resistive index (RRI)
timeFrame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Secondary outcomes:
measure: change in renal medullary oxygen tension
timeFrame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
measure: ventilatory mechanics: transpulmonary pressure
timeFrame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
measure: ventilatory mechanics: driving pressure
timeFrame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
measure: ventilatory mechanics: elastance
timeFrame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
measure: haematosis
timeFrame: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
measure: Intra abdominal pressure
timeFrame: 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
measure: Persisting effect of IAP increase in prone position when patients are back in supine position on renal resistive index
timeFrame: Two hours after patients are back in supine position
measure: Persisting effect of IAP increase in prone position when patients are back in supine position on urinary PO2
timeFrame: Two hours after patients are back in supine position
measure: Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: transpulmonary pressure
timeFrame: Two hours after patients are back in supine position
measure: Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: driving pressure
timeFrame: Two hours after patients are back in supine position
measure: Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: elastance
timeFrame: Two hours after patients are back in supine position
measure: Persisting effect of IAP increase in prone position when patients are back in supine position on haematosis
timeFrame: Two hours after patients are back in supine position
measure: Acute kidney injury
timeFrame: within 48 hours following prone position
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Hospital Grenoble University
Study officials:
References: