Midodrine in the Recovery Phase of Septic Shock

Phase 3

Withdrawn

• Conditions: Septic Shock
• Interventions: Other: Standard of Care; Drug: midodrine

• Registration Number: NCT02990546
• Lead Sponsor: University of Virginia

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.

Detailed Description

The investigators aim to investigate the use of midodrine in the recovery phase of septic shock in a randomized control trial. The investigators hypothesize that midodrine use initiated after stabilization or improving intravenous vasopressor requirement will lead to decreased length of ICU stay and length of time that intravenous vasopressors are required.

The investigators plan to enroll and consent patients at the onset of septic shock. Once IV vasopressor requirement is stabilized or decreasing, males and females will be randomized in 1:1 fashion to receive either standard clinical care or standard clinical care plus oral midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors, time needing a central line, and hospital length of stay.

Study Timeline

• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-13
• Study Start: 2017-03-01
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• • Patients aged 18-99 years old

  • Admitted to UVA medical ICU with diagnosis of septic shock.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard of Care	The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal \> 65 mmHg
Intervention	midodrine	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

Primary Outcome Measures

Name	Time	Method
ICU free days	28 days	ICU free days from first 28 days

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	up to 90 days
Central venous catheter free days	28 days
IV vasopressor free days	28 days

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States