Midodrine During Recovery From Septic Shock

November 1, 2017 updated by: Northwell Health

A Randomized Controlled Trial of Midodrine During Recovery Phase From Septic Shock

The purpose of this study is to determine whether midodrine administration decreases duration of intravenous vasopressors and intensive care unit length of stay for patients in septic shock.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • admitted to intensive care unit
  • diagnosis of septic shock on intravenous vasopressors
  • stable/decreasing doses of intravenous vasopressors
  • stable/improving organ function

Exclusion Criteria:

  • allergy to midodrine
  • multiple intravenous vasopressors
  • increasing intravenous vasopressor requirements
  • worsening organ dysfunction
  • severe bradycardia

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: midodrine
randomization to midodrine 20 mg every 8 hours to be increased to a maximum of 40 mg every 8 hours until intravenous vasopressor discontinuation
Drug: Midodrine
midodrine is metabolized to an active metabolite, desglymidodrine, which is an alpha adrenergic antagonist that causes vasoconstriction of both venous and arterial vasculature, thereby increasing blood pressure
Other Names:
  • proamatine
Placebo Comparator: placebo
randomization to placebo control
Drug: placebo
placebo will be administered to double blind the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of intravenous vasopressors
Time Frame: from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days
from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensive care unit length of stay
Time Frame: from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days
from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days
re-institution of intravenous vasopressor
Time Frame: from enrollment until hospital discharge, expected to be up to 30 days
from enrollment until hospital discharge, expected to be up to 30 days
hospital length of stay
Time Frame: from enrollment until hospital discharge, expected to be up to 30 days
from enrollment until hospital discharge, expected to be up to 30 days
mortality
Time Frame: from enrollment until hospital discharge, expected to be up to 30 days
from enrollment until hospital discharge, expected to be up to 30 days
midodrine side effects requiring discontinuation
Time Frame: from enrollment until hospital discharge, expected to be up to 30 days
including supine hypertension and bradycardia
from enrollment until hospital discharge, expected to be up to 30 days

Collaborators and Investigators

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

Sponsor

Northwell Health

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 (Anticipated)

August 1, 2017

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • temp-1187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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.

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