Midodrine in the Recovery Phase of Septic Shock

NCT ID: NCT02990546

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-05-02

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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

midodrine

Intervention Type: DRUG

Midodrine will be given to treatment arm as enteral medication

Control

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

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

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

Interventions

midodrine

Midodrine will be given to treatment arm as enteral medication

Intervention Type: DRUG

Standard of Care

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

Intervention Type: OTHER

Other Intervention Names

Midodrine Hydrochloride; Proamatine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M Jones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

19198

Identifier Type: -

Identifier Source: org_study_id