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Effect of Adding Vasopressin on Cardiac Output, Blood Pressure, Diuresis, and Tissue Perfusion Indices in Patients With Septic Shock (VASO-PHENO)

2026年7月6日更新者：Assistance Publique - Hôpitaux de Paris

In patients with septic shock, vasopressin is increasingly used in combination with norepinephrine, but its timing of initiation remains heterogeneous and its clinical hemodynamic effects are still insufficiently characterized. Available data suggest variable responses, which may depend on the hemodynamic phenotype at the time of treatment initiation. In particular, the effects of vasopressin may differ according to the presence of preload dependency, baseline cardiac output, impaired systolic function, or baseline diastolic arterial pressure, reflecting the degree of vasoplegia. In this context, the VASO-PHENO study aims to provide a detailed and dynamic description of the early hemodynamic and clinical effects of vasopressin initiation in septic shock.

To date, no clinical study has systematically and dynamically evaluated the effects of vasopressin on central and peripheral hemodynamic parameters according to the hemodynamic profile at the time of its initiation. Describing these effects appears essential to better understand the variability in clinical responses and to contribute to a more rational and personalized approach to vasopressor escalation in septic shock.

調査の概要

状態

まだ募集していません

条件

Septic Shock and Use of Vasopressin

詳細な説明

In patients with septic shock, hemodynamic profiles are highly heterogeneous. From a pathophysiological perspective, three main hemodynamic phenotypic components may contribute to the septic shock state:

preload dependency;
impaired myocardial function, leading to a cardiac output that is inadequate to meet oxygen demand;
vasoplegia.

In some of these contexts, the introduction of vasopressin, as a pure vasoconstrictor, may be inappropriate or even harmful, by impairing cardiac output or exposing the patient to excessive vasoconstriction and a subsequent risk of ischemia.

Thus:

In the presence of impaired myocardial function, defined by reduced cardiac output and/or impaired left ventricular ejection fraction, vasopressin initiation may lead to a decrease in cardiac output;
In the presence of vasoplegia, the effects of vasopressin on mean arterial pressure and microcirculatory indices, such as capillary refill time, mottling, and urine output, may vary according to the severity of the initial vasoplegia, notably reflected by diastolic arterial pressure;
In the presence of persistent preload dependency, the initiation of a pure vasoconstrictor may either increase cardiac output by increasing venous return, or worsen microcirculatory alterations by enhancing vasoconstriction in a context of hypovolemia.

To date, no study has precisely described the effects of vasopressin on macrocirculatory hemodynamic parameters, including arterial pressure, cardiac output, and central venous pressure, and on routinely assessable microcirculatory parameters, including capillary refill time, mottling, and urine output, according to the different hemodynamic phenotypic components present at the time of vasopressin initiation.

Describing the evolution of these parameters appears essential to better understand the variability in clinical responses and associated outcomes. Such an approach could help identify at-risk profiles and provide objective elements to support a more rational and personalized escalation of vasopressor therapy in septic shock.

研究の種類

観察的

入学 (推定)

200

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Xavier MONNET, MD PhD
電話番号：+33(0)145213539
メール：xavier.monnet@aphp.fr

研究連絡先のバックアップ

名前：Nicolas FAGE, MD PhD
メール：fage.nicolas@gmail.com

研究場所

フランス
- - Angers、フランス
    - CHU d'Angers
    - コンタクト：
      
      Pierre ASFAR
      
      メール：PiAsfar@chu-angers.fr
  - Dieppe、フランス
    - CH de Dieppe
    - コンタクト：
      
      Marion BEUZELIN
      
      メール：MBeuzelin@ch-dieppe.fr
  - Le Kremlin-Bicêtre、フランス
    - Hôpital Bicêtre
    - コンタクト：
      
      Xavier MONNET
      
      メール：xavier.monnet@aphp.fr
  - Lyon、フランス
    - GHE, Hôpital Louis Pradel, HCL
    - コンタクト：
      
      Matthias JACQUET-LAGREZE
      
      メール：matthias.jacquet-lagreze@chu-lyon.fr
  - Lyon、フランス
    - GHS - Hôpital Lyon Sud, HCL
    - コンタクト：
      
      Jean-Luc FELLAHI
      
      メール：jean-luc.fellahi@chu-lyon.fr
  - Marseille、フランス
    - Hôpital Nord, AP-HM
    - コンタクト：
      
      Marc LEONE
      
      メール：marc.leone@ap-hm.fr
  - Rennes、フランス
    - CHU Rennes - Site Pontchaillou
    - コンタクト：
      
      Mathieu LESOUHAITIER
      
      メール：Mathieu.LESOUHAITIER@chu-rennes.fr
  - Strasbourg、フランス
    - Hôpital Hautepierre, Hôpitaux Universitaires de Strasbourg
    - コンタクト：
      
      Julien DEMISELLE DEMISELLE
      
      メール：julien.demiselle@chru-strasbourg.fr

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Adult patients hospitalized in the intensive care unit for septic shock and with use of vasopressin

説明

Inclusion Criteria:

Age ≥ 18 years;
Hospitalized in an intensive care unit;
Presenting with septic shock according to Sepsis-3 criteria;
For whom the treating clinician wishes to initiate vasopressin as second-line therapy as part of routine care;
Undergoing hemodynamic monitoring with a PiCCO2 device (Pulsion Medical Systems, Getinge, Feldkirchen, Germany) or pulmonary artery catheterization as part of routine care.

Exclusion Criteria:

Patient already receiving vasopressin;
Pregnancy;
Patient under legal protection;
Patient unwilling to participate in the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

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
To describe and compare the evolution of cardiac index between inclusion and 20 minutes after vasopressin initiation in patients with septic shock, according to hemodynamic profiles identified a posteriori from variables collected at the time of vasopre 時間枠：T0 = inclusion. T20 = 20 minutes after the introduction of the vasopressin	Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance: presence of preload dependency at the time of vasopressin initiation (yes/no); cardiac index at inclusion; diastolic arterial pressure at inclusion; left ventricular ejection fraction (LVEF).	T0 = inclusion. T20 = 20 minutes after the introduction of the vasopressin

二次結果の測定

結果測定	メジャーの説明	時間枠
To describe the evolution of cardiac index between inclusion (T0), T1h, T3h, and T24h after vasopressin initiation 時間枠：T0 = inclusion, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	Secondary objectives will be analyzed in the overall population and, for descriptive purposes, according to the hemodynamic profiles identified by clustering analysis and according to age at inclusion. Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance: presence of preload dependency at the time of vasopressin initiation (yes/no); cardiac index at inclusion; diastolic arterial pressure at inclusion; left ventricular ejection fraction (LVEF).	T0 = inclusion, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin
Change in mean arterial pressure after vasopressin initiation 時間枠：T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	Mean arterial pressure will be measured at inclusion before vasopressin initiation and at predefined time points after vasopressin initiation. The evolution of mean arterial pressure will be described in the overall population.	T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin
In patients monitored with a Swan-Ganz® pulmonary artery catheter: to describe the evolution of pulmonary artery occlusion pressure between inclusion (T0), T20, T1h, T3h, and T24h after vasopressin initiation3. 時間枠：T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	PAPO will be assessed with a standard occlusion of the ballon in the pulmonary arteries with the use of the Swan Ganz. Secondary objectives will be analyzed in the overall population and, for descriptive purposes, according to the hemodynamic profiles identified by clustering analysis and according to age at inclusion. Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance: presence of preload dependency at the time of vasopressin initiation (yes/no); cardiac index at inclusion; diastolic arterial pressure at inclusion; left ventricular ejection fraction (LVEF).	T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin
In patients monitored with a transpulmonary thermodilution device combined with pulse contour analysis (PiCCO®): to describe the evolution of indexed extravascular lung water between inclusion (T0), T20, T1h, T3h, and T24h after vasopressin initiation 時間枠：T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	The indexed extravascular lung water will be assessed with a standard thermodilution in patients with PICCO. Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance: presence of preload dependency at the time of vasopressin initiation (yes/no); cardiac index at inclusion; diastolic arterial pressure at inclusion; left ventricular ejection fraction (LVEF).	T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin
To describe the evolution of mean arterial pressure between inclusion (T0), T20, T1h, T3h, and T24h after vasopressin initiation, according to diastolic arterial pressure at inclusion. 時間枠：T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	Secondary objectives will be analyzed in the overall population and, for descriptive purposes, according to the hemodynamic profiles identified by clustering analysis and according to age at inclusion. Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance: presence of preload dependency at the time of vasopressin initiation (yes/no); cardiac index at inclusion; diastolic arterial pressure at inclusion; left ventricular ejection fraction (LVEF).	T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin
Change in urine output during the first 24 hours after vasopressin initiation 時間枠：Urine output will be assessed every 2 hours from the introduction of vasopressine (T0) to 24 hours after the introduction of the vasopressine (T24)	Urine output will be collected every 2 hours during the first 24 hours after vasopressin initiation. The evolution of urine output will be described in the overall population.	Urine output will be assessed every 2 hours from the introduction of vasopressine (T0) to 24 hours after the introduction of the vasopressine (T24)
Change in capillary refill time after vasopressin initiation 時間枠：T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	Capillary refill time will be assessed at baseline and at predefined time points after vasopressin initiation using a standardized method. The evolution of capillary refill time will be described in the overall population.	T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin
To describe the evolution of the mottling between the introduction of vasopressin (T0), T20, T1h, T3h, and T24h after vasopressin initiation, according to the evolution of the mean arterial pressure, diastolic arterial pressure, and of the cardiac output 時間枠：T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	Mottling will be assessed in a standardized way, by the mottling score. The mottling score describe the intensy of the mottling, from 0 (no mottling) to 5 (mottling up to the abdominal skin)	T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin
To describe the evolution of arterial lactate between the introduction of vasopressin (T0), T20, T1h, T3h and T24h after vasopressin initiation, according to the evolution of the mean arterial pressure, diastolic arterial pressure and cardiac output 時間枠：T0 = inclusion, T20 = 20 minutes after the introduction of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	Arterial lactate will be assessed by a arterial blood gaz sample, if available at this different time point.	T0 = inclusion, T20 = 20 minutes after the introduction of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin
To describe the evolution of the cardiac output between the introduction of vasopressin (T0), T20, T1H, T3h and T24h after vasopressin initiation, according to the initial left ventricular ejection fraction. 時間枠：T0 = inclusion, T20 = 20 minutes after the introduction of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin	Cardiac output will be assessed with PICCO2 device or pulmonary artery catheterization. Left ventricular ejection fraction will be asssessed before adminstration of the vasopressin.	T0 = inclusion, T20 = 20 minutes after the introduction of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Assistance Publique - Hôpitaux de Paris

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2029年9月1日

研究の完了 (推定)

2029年9月1日

試験登録日

最初に提出

2026年6月22日

QC基準を満たした最初の提出物

2026年7月6日

最初の投稿 (実際)

2026年7月13日

学習記録の更新

投稿された最後の更新 (実際)