Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07836387

Driving Pressure Optimization, RV-PA Coupling, and AKI in Mechanically Ventilated Critically Ill Patients

This study evaluates the effect of driving pressure optimization on right ventricular-pulmonary artery (RV-PA) coupling, assessed by TAPSE/PASP ratio, and its association with acute kidney injury (AKI) progression in mechanically ventilated critically ill patients.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

About this study

The tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP) ratio is a validated, non-invasive bedside surrogate for RV-PA coupling, shown to correlate closely with invasively measured pressure-volume loop indices of RV-arterial coupling and to carry independent prognostic value in heart failure and pulmonary hypertension populations. More recently, TAPSE-based coupling indices have also demonstrated prognostic relevance in general critically ill populations, supporting their applicability outside the setting of chronic cardiopulmonary disease.

Separately, driving pressure (the difference between plateau pressure and PEEP) has emerged as a key determinant of ventilator-induced lung injury and mortality in ARDS, independent of tidal volume or PEEP in isolation, building on earlier evidence that lower tidal volume ventilation strategies improve outcomes in acute lung injury and ARDS.

This study will investigate whether a simple standardized lung-protective ventilation strategy aimed at optimizing ventilator driving pressure can improve RV-PA coupling, assessed by TAPSE/PASP ratio, and reduce AKI progression in mechanically ventilated critically ill patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years.
  • ICU admission.
  • Invasive mechanical ventilation expected to continue for ≥48 hours.
  • Adequate transthoracic echocardiographic acoustic window for assessment of TAPSE/PASP.

Exclusion criteria

  • Pre-existing end-stage renal disease on chronic dialysis.
  • Severe pulmonic or tricuspid valve disease precluding reliable TAPSE/PASP assessment.
  • Pre-existing RV dysfunction of a non-pulmonary cause.
  • Pregnancy.
  • Patients expected to die within 24 hours.
  • Technically inadequate echocardiographic window.
  • Clinical contraindication to the proposed ventilation strategy.

Treatment and study plan

Driving Pressure-Guided Ventilator Optimization

Other

A ventilator management strategy in which tidal volume and/or PEEP are titrated to minimize driving pressure (plateau pressure - PEEP) to a pre-specified target, aiming to improve RV-PA coupling and reduce AKI progression.

Primary outcomes

  1. TAPSE/PASP ratio (RV-PA coupling)

    Time frame: On admission and 48-72 hours after

    Baseline transthoracic echocardiography will be performed before initiation of the intervention whenever feasible, recording: TAPSE, PASP (estimated from tricuspid regurgitant jet velocity and estimated right atrial pressure), MAPSE (LV longitudinal function parameter), Inferior vena cava (IVC) collapsibility index.

    Repeat echocardiography will be performed approximately 48-72 hours after initiation of the intervention, using the same measurements.

Secondary outcomes

  1. Acute kidney injury progression

    Time frame: 1 week

    Serum creatinine and urine output will be recorded at baseline and daily for the first 7 days of mechanical ventilation, or until ICU discharge/death if earlier.

    AKI will be staged according to KDIGO criteria with primary renal endpoint:

    AKI progression, defined as an increase in KDIGO stage during the 7-day observation period. New AKI and worsening of established AKI may also be described separately.

Study contacts

Contact information is provided by the study sponsor or research team.

Nardin Girgis

CONTACT

[email protected]

+2 01285151220

Sponsors and collaborators

Lead sponsor

Nardin Aymn Boshra

Other

Collaborators

  • Assiut University

Registry information

Official study title

Effect of Driving Pressure Optimization on RV-PA Coupling (TAPSE/PASP Ratio) and Acute Kidney Injury Progression in Mechanically Ventilated Critically Ill Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

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.

Published trials that share one or more normalized conditions with this study.