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Completed

NCT Number: NCT06947616

Effect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction

The study aimed to assess the effects of mild therapeutic hypothermia (MTH) on vasopressors and inotropes in patients with cardiogenic shock (CS) due to acute myocardial infarction (AMI).

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Key information

About this study

Cardiogenic shock (CS) is a condition characterized by a severe lack of blood flow to vital organs caused by primary malfunction of the heart, as described by the European Society of Cardiology (ESC) and the American Heart Association (AHA). Acute myocardial infarction (AMI) is a prevalent etiology of CS, constituting a minimum of 30% of the instances. 50% of CS cases manifest upon hospital admission, whereas the remaining 50% occur after hospital admission.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 50 to 70 years.
  • Both sexes.
  • Cardiogenic shock post AMI defined by systolic blood pressure <90 mm Hg for >30 minutes or motropes required to maintain a systolic blood pressure >90 mm Hg in the absence of hypovolemia with signs of pulmonary congestion and signs of impaired organ perfusion defined by at least 1 of the following: altered mental status; cold, clammy skin; urine output <30 mL/h; or arterial lactate >2 mmol/L.
  • Intubated and sedated

Exclusion criteria

  • Self-ventilated
  • Indication for targeted temperature management by current guidelines "out of hospital cardiac arrest with return of spontaneous circulation (ROSC)"

Treatment and study plan

Mild therapeutic hypothermia

Drug

Patients received mild therapeutic hypothermia (MTH) to 33°C for 24-36 h

Primary outcomes

  1. Incidence of stroke

    Time frame: 30 day after the procedure

    Incidence of stroke until day 30 was recorded.

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: Up to 7 days

    Duration of mechanical ventilation was recorded.

  2. Length of intensive care unit stay

    Time frame: Up to 2 weeks after the procedure

    Length of intensive care unit (ICU) stay refers to the total duration a patient remains in the ICU, beginning from the moment of admission to the ICU until their discharge or transfer to a less intensive care setting, such as a regular hospital ward or home.

  3. Duration of inotropic support

    Time frame: Intraoperatively

    Duration of inotropic support was recorded.

  4. Incidence of mortality

    Time frame: 30 days after the procedure

    Incidence of mortality was recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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