Effectiveness of Midodrine as an Adjuvant to Norepinephrine in Weaning Critically Ill Patients From Vasopressors

Sohag University

Status: Enrolling

Conditions: Shock

Treatments: Drug: Weaning critically ill patients from norepinephrine without use of midodrine as an adjuvant; Drug: Weaning critically ill patients from norepinephrine using midodrine as an adjuvant to norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT06930235

Soh-Med--25-3-06MS

Details and patient eligibility

About

This study aims to evaluate the effectiveness of midodrine as an adjuvant to norepinephrine in weaning critically ill patients from vasopressors

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with refractory hypotension on an intravenous vasopressor for more than 24 h but deemed clinically stable.
• Patients on noradrenaline support <10 μg/min

Exclusion criteria

• Known allergy to midodrine.
• Severe shock state, as evidenced by multiple vasopressor infusions or high vasopressor requirement (i.e. noradrenaline >10 μg/min)
• Patients with severe organic heart disease (e.g., heart failure, sever aortic stenosis), pregnancy, thyrotoxicosis or pheochromocytoma.
• Those with no enteral route available.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Weaning critically ill patients from norepinephrine using midodrine as an adjuvant to norepinephrine

Active Comparator group

Description:

Patients in group I will receive midodrine (10 mg orally every 8 hours) in addition to administered concurrently with ongoing intravenous norepinephrine after being on norepinephrine for more than 24 h.

Treatment:

Drug: Weaning critically ill patients from norepinephrine using midodrine as an adjuvant to norepinephrine

Weaning critically ill patients from norepinephrine without use of midodrine as an adjuvant

Active Comparator group

Description:

Patients in group II with ongoing intravenous norepinephrine only

Treatment:

Drug: Weaning critically ill patients from norepinephrine without use of midodrine as an adjuvant