NCT07836387

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 17, 2026

Last Update Submit

September 22, 2026

Conditions

Acute Kidney FailureMechanical Ventilation StrategiesRight Ventricular (RV) DysfunctionCritical Illness

Keywords

Driving PressureRV-PA CouplingTAPSE/PASP RatioMechanical ventilationAcute Kidney InjuryKDIGO

Outcome Measures

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.

    On admission and 48-72 hours after

Secondary Outcomes (1)

  • Acute kidney injury progression

    1 week

Study Arms (2)

Driving Pressure-Optimized Ventilation Group

EXPERIMENTAL

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

Standard Ventilation Group

NO INTERVENTION

Patients ventilated according to standard ventilation practice

Interventions

Driving Pressure-Guided Ventilator OptimizationOTHER

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.

Driving Pressure-Optimized Ventilation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 33167032BACKGROUND

  • 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.

    PMID: 25693014BACKGROUND

  • 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.

    PMID: 10793162BACKGROUND

  • 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.

    PMID: 31500448BACKGROUND

  • 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.

    PMID: 31777389BACKGROUND

  • 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.

    PMID: 27337068BACKGROUND

  • 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.

    PMID: 23710662BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nardin Girgis

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Alaa El-Din Abdel-Moneim El-Sayed Othman

    Professor of internal medicine

    STUDY CHAIR

  • Radwa Awad Abd-ElHafaz

    Lecturer of internal medicine and nephorology

    STUDY DIRECTOR

Central Study Contacts

Nardin Girgis

CONTACT

+2 01285151220nadosha74@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 23, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)