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

Not Applicable

Completed

• Conditions: Mild Therapeutic Hypothermia; Cardiogenic Shock; Acute Myocardial Infarction; Vasopressors; Inotropes
• Interventions: Drug: Mild therapeutic hypothermia

• Registration Number: NCT06947616
• Lead Sponsor: Tanta University

Brief Summary

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).

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 Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-20
• Study First Submitted QC: 2025-04-20
• Last Update Submitted: 2025-04-20
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild therapeutic hypothermia group	Mild therapeutic hypothermia	Patients received mild therapeutic hypothermia (MTH) to 33°C for 24-36 h

Primary Outcome Measures

Name	Time	Method
Incidence of stroke	30 day after the procedure	Incidence of stroke until day 30 was recorded.

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	Up to 7 days	Duration of mechanical ventilation was recorded.
Length of intensive care unit stay	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.
Duration of inotropic support	Intraoperatively	Duration of inotropic support was recorded.
Incidence of mortality	30 days after the procedure	Incidence of mortality was recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt