Midodrine in the Recovery Phase of Septic Shock

NCT02990546 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 19198
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. The investigators hypothesize that the oral drug can reduce central line days and ICU length of stay.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• ICU free days

  ICU free days from first 28 days

  28 days

Secondary Outcomes (3)

• Central venous catheter free days

  28 days

• IV vasopressor free days

  28 days

• Hospital length of stay

  up to 90 days

Study Arms (2)

Intervention

EXPERIMENTAL

In the intervention arm 10 mg of midodrine will be given orally three times daily starting at the time of stable or decreasing intravenous vasopressor support

Drug: midodrine

Control

OTHER

The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal \> 65 mmHg

Other: Standard of Care

Interventions

midodrine DRUG

Midodrine will be given to treatment arm as enteral medication

Also known as: Midodrine Hydrochloride; Proamatine

Intervention

Standard of Care OTHER

Patients in the control arm will receive standard of care for septic shock

Control

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-99 years old
• Admitted to UVA medical ICU with diagnosis of septic shock.

You may not qualify if:

• Pregnant females, patients with childbearing potential will have urine pregnancy testing after consent
• Patients \< 18 years
• Prisoners
• Patients already taking midodrine
• Patients with cirrhosis and Child-Pugh Class C (Child-Pugh score \> 9)\_
• Patients with Increased intraocular pressure and glaucoma
• Patients with allergy to midodrine
• Non-English speaking patients
• Patients without enteral access
• Patients where the attending physician does not feel MAP goal of \> 65 mmHg is physiologically acceptable.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Midodrine; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert M Jones, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 13, 2016
• Study Start: March 1, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)