Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients

January 7, 2020 updated by: Dina hussein ahmed eladly, Ain Shams University
  1. Assess the impact of midodrine administration on weaning of IV vasopressors
  2. Assess the cost effectiveness of using midodrine in critically ill patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized controlled clinical trial on total 60 critically ill patients admitted to critical care medicine department with indication to IV vasopressor due to septic shock on admission or during intensive care unit stay and they are randomly assigned to either of 2 groups as follows

  1. Group 1(n=30):will receive IV vasopressor infusion only
  2. Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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
      • Cairo, Egypt
        • Critical Care Medicine Department - Cairo University Hospitals

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patients (18-80)years
  2. Hypotensive (systolic blood pressure<90mm Hg)and require IV vasopressor for more than 24 hours
  3. Require IV vasopressor at rate < 8mcg/min and unable to wean for >24 hours

Exclusion Criteria:

  1. Severe organic heart disease (ejection fraction <30 percent due to higher risk of arrythmia)
  2. Bradycardia (HR<50 b/m)due to higher likelihood of symptomatic bradycardia
  3. Chronic kidney disease (serum creatinine >2mg/dl) as midodrine and its active metabolites are almost completely execreated in urine
  4. Thyrotoxicosis
  5. Known allergy to midodrine

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: IV vasopressor
Will receive IV vasopressor infusion only
Active Comparator: Midodrine
Will receive midodrine in addition to IV vasopressor infusion
Drug: Midodrine
The oral vasoactive drug (Midodrine) at a dose of 10-20 mg every 8 hours will be used in one arm .After the blood pressure goal is met for more than 24 hours without IV vasopressor ,midodrine will be discontinued prior to discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of weaning of IV vasopressor in both groups
Time Frame: Starting from date of randomization till stop of IV vasopressor completely or date of death from any cause,whichever came first,assessed up to 30 days
measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration
Starting from date of randomization till stop of IV vasopressor completely or date of death from any cause,whichever came first,assessed up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
total duration of patient stay in ICU
Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
Time to ICU discharge after IV vasopressor discontinuation
Time Frame: Starting from discontinuation of IV vasopressor until time to ICU discharge or date of death from any cause ,whichever came first,assessed up to 30 days
measure duration from IV vasopressor stop till ICU discharge or death
Starting from discontinuation of IV vasopressor until time to ICU discharge or date of death from any cause ,whichever came first,assessed up to 30 days
Time to ICU discharge after midodrine initiation
Time Frame: Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
measure duration from midodrine start till ICU discharge or death
Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
Mortality
Time Frame: Up to 30 days
measure if patient die or discharge from the ICU
Up to 30 days

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Lamiaa ELwakeel, PhD, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 15, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 169

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Septic Shock

Clinical Trials on Midodrine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe