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Completed

NCT Number: NCT04286490

Prone Position and Renal Resistive Index

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Acute Kidney Injury Cardiovascular Diseases Compartment Syndromes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intra-Abdominal Hypertension Kidney Diseases Lung Diseases Male Urogenital Diseases Muscular Diseases Musculoskeletal Diseases Prone Position Renal Insufficiency Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Grenoble University

Grenoble, 38000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone position

Other

Abdomen suspension in prone position

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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).

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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)

  13. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Act For Chronic Diseases
  • French Society for Intensive Care

Registry information

Official study title

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

Acronym: PRO-KIDNEY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2020
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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