Prone Position and Renal Resistive Index (PRO-KIDNEY)

January 27, 2025 updated by: University Hospital, Grenoble

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Grenoble, France, 38000
        • Hospital Grenoble University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prone position
Other: Prone position
Abdomen suspension in prone position

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in renal resistive index (RRI)
Time Frame: 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).
At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in renal medullary oxygen tension
Time Frame: 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
At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: transpulmonary pressure
Time Frame: 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
At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: driving pressure
Time Frame: 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
At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
ventilatory mechanics: elastance
Time Frame: 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
At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
haematosis
Time Frame: 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)
At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver
Intra abdominal 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
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
Time Frame: 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).
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: Two hours after patients are back in supine position
arterial oxygen tension (PaO2) and arterial dioxide carbon tension (PaC02)
Two hours after patients are back in supine position
Acute kidney injury
Time Frame: within 48 hours following prone position
According to creatinine or diuresis criteria of Kidney Disease: Improving Global Outcomes (K-DIGO) classification
within 48 hours following prone position

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
French Society for Intensive Care
Act For Chronic Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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