Midodrine During Recovery From Septic Shock

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02771158
• Other study ID #: temp-1187
• Status: Withdrawn
• Phase: Phase 4
• First received: March 28, 2016
• Last updated: November 1, 2017
• Start date: August 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2017
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Sepsis
• Shock
• Shock, Septic

Intervention

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
• placebo
placebo will be administered to double blind the study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of intravenous vasopressors		from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days
Secondary	intensive care unit length of stay		from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days
Secondary	re-institution of intravenous vasopressor		from enrollment until hospital discharge, expected to be up to 30 days
Secondary	hospital length of stay		from enrollment until hospital discharge, expected to be up to 30 days
Secondary	mortality		from enrollment until hospital discharge, expected to be up to 30 days
Secondary	midodrine side effects requiring discontinuation	including supine hypertension and bradycardia	from enrollment until hospital discharge, expected to be up to 30 days