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

NCT06947616 | Completed

• 1 other identifier: 33716/3/20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of stroke

  Incidence of stroke until day 30 was recorded.

  30 day after the procedure

Secondary Outcomes (4)

• Duration of mechanical ventilation

  Up to 7 days

• Length of intensive care unit stay

  Up to 2 weeks after the procedure

• Duration of inotropic support

  Intraoperatively

• Incidence of mortality

  30 days after the procedure

Study Arms (2)

Mild therapeutic hypothermia group

EXPERIMENTAL

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

Drug: Mild therapeutic hypothermia

Control group

NO INTERVENTION

Patients did not receive mild therapeutic hypothermia (MTH)

Interventions

Mild therapeutic hypothermia DRUG

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

Mild therapeutic hypothermia group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Cardiology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 27, 2025
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)