Midodrine in the Recovery Phase of Septic Shock

University of Virginia

Status and phase: Withdrawn; Phase 3

Conditions: Septic Shock

Treatments: Other: Standard of Care; Drug: midodrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02990546

19198

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: midodrine

Control

Other group

Description:

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

Treatment:

Other: Standard of Care