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Assessing Catecholamine Treatment Initiation Options: Norepinephrine vs Dopamine for Cardiogenic Shock (ACTION-CS)

2026年4月28日 更新者：Min Chul Kim、Chonnam National University Hospital

The goal of this multicenter, open-label, randomized clinical trial is to learn whether norepinephrine or dopamine is more effective and safer as the first-line vasoactive drug for treating cardiogenic shock in adults. Cardiogenic shock is a life-threatening condition in which the heart cannot pump enough blood to supply the body. The main questions this study aims to answer are:

Does norepinephrine reduce the risk of death or worsening cardiogenic shock compared with dopamine?

Does norepinephrine lead to fewer complications such as arrhythmias, the need for mechanical circulatory support, or cardiac arrest?

Researchers will compare norepinephrine and dopamine to see which drug better stabilizes blood pressure, improves tissue perfusion, and prevents progression of shock during the early phase of treatment.

Participants will:

Be randomly assigned to receive either norepinephrine or dopamine as the first vasoactive drug

Receive treatment and monitoring based on current clinical guidelines for cardiogenic shock

Undergo regular assessments of blood pressure, laboratory values, heart rhythm, and organ function during hospitalization

Be followed for outcomes at 1 month, 6 months, and 1 year after enrollment

This study aims to provide evidence that will help determine which initial vasoactive drug offers better outcomes for patients with cardiogenic shock and guide future treatment recommendations.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Cardiogenic shock is a severe form of acute circulatory failure characterized by inadequate cardiac output, tissue hypoperfusion, and high short-term mortality. Despite advances in revascularization, mechanical circulatory support, and critical care management, early hemodynamic stabilization remains a major determinant of clinical outcomes. Vasoactive drugs are essential components of initial therapy, yet the optimal first-line agent for cardiogenic shock has not been definitively established.

Norepinephrine and dopamine are widely used vasoactive agents, but they may exert their effects through different physiological mechanisms. Their relative impact on vascular tone, cardiac output, and heart rate can vary depending on dose, patient characteristics, and the underlying pathophysiology of shock. Prior studies, including observational analyses and a landmark randomized trial, have suggested potential differences in safety profiles-particularly regarding arrhythmias-but these findings have not been confirmed in a contemporary population with standardized shock definitions and modern management strategies.

This multicenter, open-label, randomized clinical trial is designed to compare norepinephrine and dopamine as the initial vasoactive drug in adults with cardiogenic shock. The study uses a protocol-defined dosing algorithm to ensure consistent titration and incorporates current guideline-based management across participating centers. The primary endpoint evaluates both early hemodynamic deterioration and 28-day mortality, reflecting clinically meaningful outcomes during the most vulnerable phase of shock.

By enrolling a large, diverse population across multiple centers, this trial aims to provide definitive evidence regarding the comparative effectiveness and safety of norepinephrine versus dopamine as first-line therapy. The results are expected to inform clinical guidelines and support standardized treatment strategies for patients with cardiogenic shock.

研究の種類

介入

入学 (推定)

512

段階

  • 適用できない

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：Min Chul Kim, Professor, MD, PhD
  • 電話番号：82-10-4606-2643
  • メール：kmc3242@hanmail.net

研究連絡先のバックアップ

  • 名前：Yongwhan Lim, Professor, MD
  • 電話番号：82-10-3229-3392
  • メール：kalmiarmfl@naver.com

研究場所

  • 韓国
      • Gwangju、韓国、61469
        • Chonnam National University Hospital

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

説明

Inclusion Criteria: 1&2

  1. Age ≥ 19

  2. Cardiogenic shocka in the stage of Society for cardiovascular angiography and intervention (SCAI) C or D

    • Cardiogenic shock was defined as follows, and should fulfill both 1) and 2)

      1. systolic blood pressure <90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure >90 mm Hg And
      2. Impaired cardiac function confirmed by cardiac catheterization or echocardiography

    • Patients will be further classified based on the SCAI shock classification system as follows:

      1. SCAI B: no signs of hypoperfusion
      2. SCAI C: any signs of hypoperfusion, cardiogenic shock will be classified as SCAI C, and these include mental status change, cool and clammy skin, mottled skin appearance, decreased urine output (30ml/hour) or lactate over 2.0mmol/L
      3. SCAI D: requirement of second-line vasoactive drug or mechanical circulatory support based on the predefined treatment protocol

Exclusion Criteria: any of these,

  1. Administration of vasoactive drug more than 6 hours before enrollment
  2. Patients already on temporary mechanical circulatory supportb before enrollment
  3. Glasgow Coma Scale lower than 8 or other evidence of irreversible brain injury
  4. Shock etiologies other than cardiogenic which include postcardiotomy shock or mixed shock
  5. Pregnancy or lactation

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

  • 主な目的：処理
  • 割り当て：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
実験的：Norepinephrine First-Line Vasoactive Drug
Participants assigned to this arm will receive norepinephrine as the first-line vasoactive drug for the treatment of cardiogenic shock. The drug will be initiated and titrated according to the protocol-defined dosing algorithm, with adjustments based on hemodynamic response, laboratory values, and clinical status. If participants were receiving vasoactive agents before randomization, norepinephrine will be started at an equivalent protocol-defined dose, and other agents will be tapered as clinically appropriate. All treatment and monitoring will follow current clinical guidelines for cardiogenic shock.
薬：Norepinephrine
Norepinephrine will be administered as an intravenous continuous infusion and used as the first-line vasoactive drug for the treatment of cardiogenic shock. The medication will be prepared in standard intensive care unit infusion bags and delivered through a controlled infusion pump. The infusion will be initiated and titrated according to a protocol-defined dosing algorithm, with adjustments based on blood pressure, hemodynamic response, laboratory values, and overall clinical assessment. If a participant was receiving vasoactive agents before randomization, norepinephrine will be started at an equivalent protocol-defined dose, and non-assigned agents will be tapered as clinically appropriate. The duration of infusion will depend on the participant's clinical stabilization. All administration and monitoring will follow current clinical guidelines for cardiogenic shock.
アクティブコンパレータ：Dopamine First-Line Vasoactive Drug
articipants assigned to this arm will receive dopamine as the first-line vasoactive drug for the treatment of cardiogenic shock. The drug will be initiated and titrated according to the protocol-defined dosing algorithm, with adjustments based on hemodynamic response, laboratory values, and clinical status. If participants were receiving vasoactive agents before randomization, dopamine will be started at an equivalent protocol-defined dose, and other agents will be tapered as clinically appropriate. All treatment and monitoring will follow current clinical guidelines for cardiogenic shock.
薬：Dopamine Agent
Dopamine will be administered as an intravenous continuous infusion and used as the first-line vasoactive drug for the treatment of cardiogenic shock. The medication will be prepared in standard intensive care unit infusion bags and delivered through a controlled infusion pump. The infusion will be initiated and titrated according to a protocol-defined dosing algorithm, with adjustments based on blood pressure, hemodynamic response, laboratory values, and overall clinical assessment. If a participant was receiving vasoactive agents before randomization, dopamine will be started at an equivalent protocol-defined dose, and non-assigned agents will be tapered as clinically appropriate. The duration of infusion will depend on the participant's clinical stabilization. All administration and monitoring will follow current clinical guidelines for cardiogenic shock.

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
A composite of 28-day all-cause death or signs of progressive or refractory cardiogenic shock within the first 24 hours
時間枠：28 days

signs of progressive or refractory cardiogenic shock within the first 24 hours, defined as follows, any of:

  • Sustained low blood pressure (mean arterial pressure < 60mmHg) more than 30 minutes
  • Lactate over 4 mmol/L, higher than initial lactate level at 6 hours after randomization
  • Initiation of treatment with mechanical circulatory support
  • Initiation of second-line vasoactive drug
  • Cardiac arrest requiring cardiopulmonary resuscitation
  • Arrhythmia requiring electrical cardioversion **For patients who experience more than one qualifying event, the primary endpoint will be determined based on the first event that occurs.
28 days

二次結果の測定

結果測定
メジャーの説明
時間枠
All-cause death at 28th day
時間枠：28 days
28 days
Cardiovascular death at 28th day
時間枠：28 days
28 days
Number of participants who develop signs of progressive or refractory cardiogenic shock within the first 24 hours
時間枠：the first 24 hours

defined as follows, any of:

  • Sustained low blood pressure (mean arterial pressure < 60mmHg) more than 30 minutes
  • Lactate over 4 mmol/L, higher than initial lactate level at 6 hours after randomization
  • Initiation of treatment with mechanical circulatory support
  • Initiation of second-line vasoactive drug
  • Cardiac arrest requiring cardiopulmonary resuscitation
  • Arrhythmia requiring electrical cardioversion
the first 24 hours
Number of participants who initiate mechanical circulatory support within the first 24 hours
時間枠：the first 24 hours
Impella, ECMO or IABP
the first 24 hours
Number of participants who initiate a second-line vasoactive drug within the first 24 hours
時間枠：the first 24 hours
the first 24 hours
Number of participants with cardiac arrest requiring cardiopulmonary resuscitation within the first 24 hours
時間枠：the first 24 hours
the first 24 hours
Number of participants with arrhythmia requiring electrical cardioversion within the first 24 hours
時間枠：the first 24 hours
the first 24 hours
Number of participants who receive cardiac replacement treatment (temporary or durable mechanical circulatory support or heart transplantation) within the first 28 days
時間枠：First 28 days
Temporary mechanical circulatory support include Impella, ECMO or IABP.
First 28 days
Number of participants with first-time initiation of renal replacement therapy for acute kidney injury (AKI) during initial hospitalization
時間枠：First 28 days
First 28 days
Duration of vasoactive drug use (hours) during initial hospitalization
時間枠：First 28 days
Discontinuation of vasoactive drugs is defined as the point when they are no longer required for more than 24 hours and there is no recurrence of shock.
First 28 days
Number of participants with new-onset or recurrent atrial or ventricular arrhythmia requiring pharmacologic or electrical cardioversion during initial hospitalization
時間枠：First 28 days
First 28 days
Number of participants who develop acute limb ischemia requiring surgical or interventional treatment during initial hospitalization
時間枠：First 28 days
First 28 days
Number of participants who develop ischemic or hemorrhagic stroke during initial hospitalization
時間枠：First 28 days
First 28 days
All-cause death at 1 year
時間枠：1 year
1 year
Cardiovascular death at 1 year
時間枠：1 year
1 year
Number of participants with rehospitalization due to heart failure within 1 year
時間枠：1 year
1 year
Number of participants with first-time initiation of renal replacement therapy at 1 year
時間枠：1 year
1 year

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

Chonnam National University Hospital

捜査官

  • 主任研究者：Min Chul Kim, Professor, MD, PhD、Chonnam National University Hospital
  • スタディチェア：Min Chul Kin, Professor, MD, PhD、Chonnam National University Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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5月31日

一次修了 (推定)

2031年5月31日

研究の完了 (推定)

2032年5月31日

試験登録日

最初に提出

2026年4月22日

QC基準を満たした最初の提出物

2026年4月28日

最初の投稿 (実際)

2026年5月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月1日

QC基準を満たした最後の更新が送信されました

2026年4月28日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CNUH-2026-098

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?

いいえ

IPD プランの説明

ndividual participant data (IPD) will not be shared because of privacy considerations, regulatory requirements, and institutional policies governing the handling of sensitive clinical information. The study involves critically ill patients with cardiogenic shock, and sharing detailed participant-level data may pose risks to confidentiality. Only aggregated study results will be made publicly available.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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