Intravenous Metoprolol in Septic Shock

January 28, 2025 updated by: Sherouk Rafik, Alexandria University

EFFECT of INTRAVENOUS METOPROLOL TARTRATE on MORTALITY in PATIENTS with SEPTIC SHOCK DUE to VENTILATOR-ASSOCIATED PNEUMONIA Thesis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A RCT, conducted at alexandria main university hospital, patients were divided into 2 groups, Control group which received the standard care for septic shock and metoprolol group which recieved intravenous metoprolol then patients were assessed for Blood pressure, heart rate, iv fluids needed, vasopressor doses and 28 days mortality

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Main University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metoprolol group
The group that received intravenous metoprolol
Drug: Intravenous metoprolol tartrate
An intravenous beta-blockers, recieved FDA approval
Placebo Comparator: Control group
The group that received standard care
Other: Standard Care (in control arm)
Standard care according to surviving sepsis campaign

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28-day Mortality
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU stay
Time Frame: 28 days
28 days
ventilator days
Time Frame: 28 days
28 days
iv fluids
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

November 10, 2024

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0106979

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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