Midodrine in the Recovery Phase of Septic Shock

Septic Shock Clinical Trial

Official title:

Midodrine Use in the Recovery Phase of Septic Shock

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02990546
• Other study ID #: 19198
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 1, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: January 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• midodrine
Midodrine will be given to treatment arm as enteral medication

Other:
• Standard of Care
Patients in the control arm will receive standard of care for septic shock

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU free days	ICU free days from first 28 days	28 days
Secondary	Central venous catheter free days		28 days
Secondary	IV vasopressor free days		28 days
Secondary	Hospital length of stay		up to 90 days