Midodrine During Recovery From Septic Shock

NCT02771158 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: temp-1187
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypotension; Shock, Septic; Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• duration of intravenous vasopressors

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

Secondary Outcomes (5)

• intensive care unit length of stay

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

• re-institution of intravenous vasopressor

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

• hospital length of stay

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

• mortality

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

• midodrine side effects requiring discontinuation

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

Study Arms (2)

midodrine

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

randomization to placebo control

Drug: placebo

Interventions

Midodrine DRUG

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

Also known as: proamatine

midodrine

placebo DRUG

placebo will be administered to double blind the study

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead

Related 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.

  PMID: 26953217 BACKGROUND

MeSH Terms

Conditions

Hypotension; Shock, Septic; Sepsis

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: May 12, 2016
• Study Start: August 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share