Intravenous Metoprolol in Septic Shock

NCT06592547 | Completed Phase 2 FDA Drug

• 1 other identifier: 0106979
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A RCT designed to assess the effect of giving intravenous beta-blockers in patients with septic shock after achieving hemodynamic stability. The principle of this study is to control heart rate allowing for better diastolic filling and thus better perfusion.

Conditions

Septic Shock; Ventilator Acquired Pneumonia

Keywords

Beta blockers; septic shock; Rate control; mortality

Outcome Measures

Primary Outcomes (1)

• 28-day Mortality

  28 days

Secondary Outcomes (3)

• ICU stay

  28 days

• ventilator days

  28 days

• iv fluids

  28 days

Study Arms (2)

Metoprolol group

ACTIVE COMPARATOR

The group that received intravenous metoprolol

Drug: Intravenous metoprolol tartrate

Control group

PLACEBO COMPARATOR

The group that received standard care

Other: Standard Care (in control arm)

Interventions

Intravenous metoprolol tartrate DRUG

An intravenous beta-blockers, recieved FDA approval

Metoprolol group

Standard Care (in control arm) OTHER

Standard care according to surviving sepsis campaign

Control group

Eligibility Criteria

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

You may qualify if:

• The study population included adult patients (≥ 18 years) diagnosed with septic shock secondary to VAP with sinus tachycardia, from April 1, 2022, to April 31, 2023. Septic shock was defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). VAP was identified as per the guidelines provided by the American Thoracic Society and Infectious Diseases Society of America.

You may not qualify if:

• Patients were excluded if they had contraindications to beta-blockers, had a history of heart failure, or had been receiving beta-blockers prior to the septic shock. Patients were also excluded if they developed complications from beta- blockers administration.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main university hospital

Alexandria, Egypt

Location

MeSH Terms

Conditions

Shock, Septic; Pneumonia, Ventilator-Associated

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: April 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: November 10, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

EG (1)