Driving Pressure Optimization, RV-PA Coupling, and AKI in Mechanically Ventilated Critically Ill Patients
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Nardin Girgis
- Telefonnummer: +2 01285151220
- E-post: nadosha74@gmail.com
Studieorter
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-
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Asyut, Egypten
- Assiut University
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Kontakt:
- Nardin Girgis
- Telefonnummer: +20128515220
- E-post: nadosha74@gmail.com
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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. |
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Inget ingripande: Standard Ventilation Group
Patients ventilated according to standard ventilation practice |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
TAPSE/PASP ratio (RV-PA coupling)
Tidsram: On admission and 48-72 hours after
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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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acute kidney injury progression
Tidsram: 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. |
1 week
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Nardin Girgis, Assiut University
- Studiestol: Alaa El-Din Abdel-Moneim El-Sayed Othman, Professor of internal medicine
- Studierektor: Radwa Awad Abd-ElHafaz, Lecturer of internal medicine and nephorology
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
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Andra studie-ID-nummer
- Driving Pressure Optimization
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