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Prone Position and Renal Resistive Index (PRO-KIDNEY)

Primary Purpose

Acute Respiratory Distress Syndrome, Acute Kidney Injury, Prone Position

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Prone position

About this trial

This is an interventional other trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prone position

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

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

ventilatory mechanics: transpulmonary pressure

transpulmonary pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger

ventilatory mechanics: driving pressure

driving pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger

ventilatory mechanics: elastance

elastance will be measured at the end of inspiration and expiration and continuously recorded on a datalogger

haematosis

arterial oxygen tension (PaO2) and arterial dioxide carbon tension (PaC02)

Intra abdominal pressure

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

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

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

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

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

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

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)

Acute kidney injury

According to creatinine or diuresis criteria of Kidney Disease: Improving Global Outcomes (K-DIGO) classification

Full Information

NCT ID

NCT04286490

First Posted

February 18, 2020

Last Updated

May 11, 2020

Sponsor

University Hospital, Grenoble

Collaborators

French Society for Intensive Care, Act For Chronic Diseases

1. Study Identification

Unique Protocol Identification Number

NCT04286490

Brief Title

Prone Position and Renal Resistive Index

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 2020 (Anticipated)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

French Society for Intensive Care, Act For Chronic Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome, Acute Kidney Injury, Prone Position, Intra-Abdominal Hypertension

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prone position

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Prone position

Intervention Description

Abdomen suspension in prone position

Primary Outcome Measure Information:

Title

change in renal resistive index (RRI)

Description

Time Frame

At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Secondary Outcome Measure Information:

Title

change in renal medullary oxygen tension

Description

urinary oxygen tension (uPO₂) will be measured via a fiber-optic luminescence optode inserted through the bladder catheter lumen

Time Frame

At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Title

change in cell-cycle arrest biomarkers

Description

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

Time Frame

At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Title

ventilatory mechanics: transpulmonary pressure

Description

transpulmonary pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger

Time Frame

At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Title

ventilatory mechanics: driving pressure

Description

driving pressure will be measured at the end of inspiration and expiration and continuously recorded on a datalogger

Time Frame

At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Title

ventilatory mechanics: elastance

Description

elastance will be measured at the end of inspiration and expiration and continuously recorded on a datalogger

Time Frame

At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Title

haematosis

Description

arterial oxygen tension (PaO2) and arterial dioxide carbon tension (PaC02)

Time Frame

At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Title

Intra abdominal pressure

Description

Intra abdominal pressure will be measured thanks to a dedicated nasogastric tube with two balloons (gastric 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

Title

Persisting effect of IAP increase in prone position when patients are back in supine position on renal resistive index

Description

Time Frame