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

NCT06930235 | Completed

• 1 other identifier: Soh-Med--25-3-06MS
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shock

Outcome Measures

Primary Outcomes (1)

• follow up of critically ill patients on vasopressors

  time of weaning from intravenous vasopressor (norepinephrine)

  48 hours

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

Patients in group II with ongoing intravenous norepinephrine only

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

Interventions

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

• 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 hrs.

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 DRUG

Patients in group II with ongoing intravenous norepinephrine only

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (3)

• Costa-Pinto R, Yong ZT, Yanase F, Young C, Brown A, Udy A, Young PJ, Eastwood G, Bellomo R. A pilot, feasibility, randomised controlled trial of midodrine as adjunctive vasopressor for low-dose vasopressor-dependent hypotension in intensive care patients: The MAVERIC study. J Crit Care. 2022 Feb;67:166-171. doi: 10.1016/j.jcrc.2021.11.004. Epub 2021 Nov 18.

  PMID: 34801917 BACKGROUND

• Hammond DA, Smith MN, Peksa GD, Trivedi AP, Balk RA, Menich BE. Midodrine as an Adjuvant to Intravenous Vasopressor Agents in Adults With Resolving Shock: Systematic Review and Meta-Analysis. J Intensive Care Med. 2020 Nov;35(11):1209-1215. doi: 10.1177/0885066619843279. Epub 2019 Apr 28.

  PMID: 31030630 BACKGROUND

• Hamed M, Elseidy SA, Elkheshen A, Maher J, Elmoghrabi A, Zaghloul A, Panakos A, Panaich S, Saad M, Elbadawi A. The Use of Midodrine as an Adjunctive Therapy to Liberate Patients from Intravenous Vasopressors: A Systematic Review and Meta-analysis of Randomized Controlled Studies. Cardiol Ther. 2023 Mar;12(1):185-195. doi: 10.1007/s40119-023-00301-0. Epub 2023 Jan 21.

  PMID: 36670331 BACKGROUND

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Sohag University

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: March 13, 2025
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

EG (1)