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

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

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).

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction; Cardiogenic Shock; Inotropes; Vasopressors; Mild Therapeutic Hypothermia
• Intervention / Treatment: Drug: Mild therapeutic hypothermia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

  2. Intubated and sedated

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild therapeutic hypothermia group; Patients received mild therapeutic hypothermia (MTH) to 33°C for 24-36 h	Drug: Mild therapeutic hypothermia; Patients received mild therapeutic hypothermia (MTH) to 33°C for 24-36 h
No Intervention: Control group; Patients did not receive mild therapeutic hypothermia (MTH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of stroke	Incidence of stroke until day 30 was recorded.	30 day after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation	Duration of mechanical ventilation was recorded.	Up to 7 days
Length of intensive care unit stay	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.	Up to 2 weeks after the procedure
Duration of inotropic support	Duration of inotropic support was recorded.	Intraoperatively
Incidence of mortality	Incidence of mortality was recorded.	30 days after the procedure

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Body Temperature Changes; Shock, Cardiogenic; Shock; Hypothermia; Myocardial Infarction; Infarction
• Other Study ID Numbers: 33716/3/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No