Acute Kidney FailureNCT07836387
Driving Pressure Optimization, RV-PA Coupling, and AKI in Mechanically Ventilated Critically Ill Patients
A study testing Driving Pressure-Guided Ventilator Optimization in people with Acute Kidney Failure and Mechanical Ventilation Strategies, run by Nardin Aymn Boshra at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure, Mechanical Ventilation Strategies, Right Ventricular (RV) Dysfunction
- What is being tested?
- Driving Pressure-Guided Ventilator Optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- ICU admission.
- Invasive mechanical ventilation expected to continue for ≥48 hours.
- Adequate transthoracic echocardiographic acoustic window for assessment of TAPSE/PASP.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut
Nardin Girgis, +20128515220, nadosha74@gmail.com
About this study
Official title: Effect of Driving Pressure Optimization on RV-PA Coupling (TAPSE/PASP Ratio) and Acute Kidney Injury Progression 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.
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.
- Conditions
- Acute Kidney Failure, Mechanical Ventilation Strategies, Right Ventricular (RV) Dysfunction, Critical Illness
- Being tested
- Driving Pressure-Guided Ventilator Optimization
- Keywords
- Driving Pressure, RV-PA Coupling, TAPSE/PASP Ratio, Mechanical ventilation, Acute Kidney Injury, KDIGO
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Driving Pressure-Guided Ventilator Optimization |
| Standard Ventilation Group | No intervention | Patients ventilated according to standard ventilation practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nardin Aymn Boshra
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Nardin Aymn Boshra, Assiut University
- Investigators
- Nardin Girgis, Principal investigator, Assiut UniversityAlaa El-Din Abdel-Moneim El-Sayed Othman, Study chair, Professor of internal medicineRadwa Awad Abd-ElHafaz, Study director, Lecturer of internal medicine and nephorology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836387
- Sponsor's protocol ID
- Driving Pressure Optimization
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33167032Amato 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 25693014Acute 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 10793162Tello 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 31500448Ronco 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 31777389Husain-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 27337068van 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Driving Pressure Optimization on RV-PA Coupling (TAPSE/PASP Ratio) and Acute Kidney Injury Progression in Mechanically Ventilated Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07836387
- Acronym / sponsor ID
- Driving Pressure Optimization
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nardin Aymn BoshraUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driving Pressure-Optimized Ventilation Group | Experimental | Other: Driving Pressure-Guided Ventilator OptimizationPatients 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. |
| Standard Ventilation Group | No intervention | –Patients ventilated according to standard ventilation practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- ICU admission.
- Invasive mechanical ventilation expected to continue for ≥48 hours.
- Adequate transthoracic echocardiographic acoustic window for assessment of TAPSE/PASP.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving Pressure-Guided Ventilator OptimizationA 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. | Other | Driving Pressure-Optimized Ventilation Group |
Primary outcome
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.
1 secondary outcome
Acute kidney injury progression
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 33167032Schmeisser 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.
- Background: PubMed 25693014Amato 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.
- Background: PubMed 10793162Acute 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.
- Background: PubMed 31500448Tello 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.
- Background: PubMed 31777389Ronco C, Bellomo R, Kellum JA. Acute kidney injury. Lancet. 2019 Nov 23;394(10212):1949-1964. doi: 10.1016/S0140-6736(19)32563-2.
- Background: PubMed 27337068Husain-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.
- Background: PubMed 23710662van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving Pressure-Guided Ventilator Optimization in people with Acute Kidney Failure and Mechanical Ventilation Strategies, run by Nardin Aymn Boshra at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nardin Girgis (+2 01285151220, nadosha74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAPSE/PASP ratio (RV-PA coupling) (time frame: On admission and 48-72 hours after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07836387, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.