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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Nardin Girgis
- 電話番号：+2 01285151220
- メール：nadosha74@gmail.com
研究場所
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-
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Asyut、エジプト
- Assiut University
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コンタクト：
- Nardin Girgis
- 電話番号：+20128515220
- メール：nadosha74@gmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：Standard Ventilation Group
Patients ventilated according to standard ventilation practice |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
TAPSE/PASP ratio (RV-PA coupling)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute kidney injury progression
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nardin Girgis、Assiut University
- スタディチェア：Alaa El-Din Abdel-Moneim El-Sayed Othman、Professor of internal medicine
- スタディディレクター：Radwa Awad Abd-ElHafaz、Lecturer of internal medicine and nephorology
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Driving Pressure Optimization
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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