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Not yet recruitingNCT07836387Updated Sep 23, 2026

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

An interventional study of Driving Pressure-Guided Ventilator Optimization in Acute Kidney Failure, Mechanical Ventilation Strategies and Right Ventricular (RV) Dysfunction, sponsored by Nardin Aymn Boshra. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Nardin Aymn Boshra · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Acute Kidney Failure
  • Mechanical Ventilation Strategies
  • Right Ventricular (RV) Dysfunction
  • Critical Illness

Keywords

  • Driving Pressure
  • RV-PA Coupling
  • TAPSE/PASP Ratio
  • Mechanical ventilation
  • Acute Kidney Injury
  • KDIGO
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Driving Pressure-Optimized Ventilation Group

    Patients ventilated using a standardized protocol targeting driving pressure optimization (ΔP ≤15 cmH2O\]) through adjustment of tidal volume and/or PEEP, in addition to standard critical care management.

    Other: Driving Pressure-Guided Ventilator Optimization

  • No intervention
    Standard Ventilation Group

    Patients ventilated according to standard ventilation practice

Interventions

  • OtherDriving Pressure-Guided Ventilator Optimization

    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.

05

What researchers measure

Primary outcomes

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

    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.

    Time frame: On admission and 48-72 hours after

Secondary outcomes

  1. Acute kidney injury progression

    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.

    Time frame: 1 week

06

Study locations

1 site
07

References and documents

Publications

  • Schmeisser A, Rauwolf T, Groscheck T, Kropf S, Luani B, Tanev I, Hansen M, Meissler S, Steendijk P, Braun-Dullaeus RC. Pressure-volume loop validation of TAPSE/PASP for right ventricular arterial coupling in heart failure with pulmonary hypertension. Eur Heart J Cardiovasc Imaging. 2021 Jan 22;22(2):168-176. doi: 10.1093/ehjci/jeaa285. PubMed 33167032 ↗
  • Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639. PubMed 25693014 ↗
  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. PubMed 10793162 ↗
  • Tello K, Wan J, Dalmer A, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Mohajerani E, Seeger W, Herberg U, Sommer N, Gall H, Richter MJ. Validation of the Tricuspid Annular Plane Systolic Excursion/Systolic Pulmonary Artery Pressure Ratio for the Assessment of Right Ventricular-Arterial Coupling in Severe Pulmonary Hypertension. Circ Cardiovasc Imaging. 2019 Sep;12(9):e009047. doi: 10.1161/CIRCIMAGING.119.009047. Epub 2019 Sep 10. PubMed 31500448 ↗
  • Ronco C, Bellomo R, Kellum JA. Acute kidney injury. Lancet. 2019 Nov 23;394(10212):1949-1964. doi: 10.1016/S0140-6736(19)32563-2. PubMed 31777389 ↗
  • Husain-Syed F, Slutsky AS, Ronco C. Lung-Kidney Cross-Talk in the Critically Ill Patient. Am J Respir Crit Care Med. 2016 Aug 15;194(4):402-14. doi: 10.1164/rccm.201602-0420CP. PubMed 27337068 ↗
  • van den Akker JP, Egal M, Groeneveld AB. Invasive mechanical ventilation as a risk factor for acute kidney injury in the critically ill: a systematic review and meta-analysis. Crit Care. 2013 May 27;17(3):R98. doi: 10.1186/cc12743. PubMed 23710662 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07836387
Lead sponsor
Nardin Aymn Boshra
Collaborators
Assiut University
Responsible party
Nardin Aymn Boshra (Assistant lecturer, Assiut University) — Sponsor-investigator
First posted
Sep 23, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Completion
Apr 1, 2028 (estimated)
Last update
Sep 23, 2026

Study contacts

Nardin Girgis
Contact
nadosha74@gmail.com
+2 01285151220
Nardin Girgis
principal investigator · Assiut University
Alaa El-Din Abdel-Moneim El-Sayed Othman
study chair · Professor of internal medicine
Radwa Awad Abd-ElHafaz
study director · Lecturer of internal medicine and nephorology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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