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

NCT ID: NCT06947616

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-10-01

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.

Conditions

Mild Therapeutic Hypothermia; Cardiogenic Shock; Acute Myocardial Infarction; Vasopressors; Inotropes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild therapeutic hypothermia group

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

Group Type: EXPERIMENTAL

Mild therapeutic hypothermia

Intervention Type: DRUG

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

Control group

Patients did not receive mild therapeutic hypothermia (MTH)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mild therapeutic hypothermia

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

Intervention Type: DRUG

Eligibility Criteria

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)"

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdelrazek Abdelmonem Abdelaal

Resident of Cardiology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

33716/3/20

Identifier Type: -

Identifier Source: org_study_id