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Midodrine During Recovery From Septic Shock

Primary Purpose

Hypotension, Shock, Septic, Sepsis

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Midodrine

placebo

About this trial

This is an interventional supportive care trial for Hypotension focused on measuring critical care, shock, septic, sepsis, hypotension, midodrine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

midodrine

placebo

Arm Description

randomization to midodrine 20 mg every 8 hours to be increased to a maximum of 40 mg every 8 hours until intravenous vasopressor discontinuation

randomization to placebo control

Outcomes

Primary Outcome Measures

duration of intravenous vasopressors

Secondary Outcome Measures

intensive care unit length of stay

re-institution of intravenous vasopressor

hospital length of stay

mortality

midodrine side effects requiring discontinuation

including supine hypertension and bradycardia

Full Information

NCT ID

NCT02771158

First Posted

March 28, 2016

Last Updated

November 1, 2017

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT02771158

Brief Title

Midodrine During Recovery From Septic Shock

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Study never started

Study Start Date

August 2017 (Anticipated)

Primary Completion Date

November 1, 2017 (Actual)

Study Completion Date

November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension, Shock, Septic, Sepsis

Keywords

critical care, shock, septic, sepsis, hypotension, midodrine

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

midodrine

Arm Type

Experimental

Arm Description

randomization to midodrine 20 mg every 8 hours to be increased to a maximum of 40 mg every 8 hours until intravenous vasopressor discontinuation

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

randomization to placebo control

Intervention Type

Drug

Intervention Name(s)

Midodrine

Other Intervention Name(s)

proamatine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo will be administered to double blind the study

Primary Outcome Measure Information:

Title

duration of intravenous vasopressors

Time Frame

from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days

Secondary Outcome Measure Information:

Title

intensive care unit length of stay

Time Frame

from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days

Title

re-institution of intravenous vasopressor

Time Frame

from enrollment until hospital discharge, expected to be up to 30 days

Title

hospital length of stay

Time Frame

from enrollment until hospital discharge, expected to be up to 30 days

Title

mortality

Time Frame

from enrollment until hospital discharge, expected to be up to 30 days

Title

midodrine side effects requiring discontinuation

Description

including supine hypertension and bradycardia

Time Frame

from enrollment until hospital discharge, expected to be up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26953217

Citation

Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.

Results Reference

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Midodrine During Recovery From Septic Shock

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