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

NCT ID: NCT06930235

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2025-10-13

Brief Summary

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

Detailed Description

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Conditions

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Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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 without use of midodrine as an adjuvant

Patients in group II with ongoing intravenous norepinephrine only

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Patients in group II with ongoing intravenous norepinephrine only

Interventions

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

• 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.

Intervention Type DRUG

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

Patients in group II with ongoing intravenous norepinephrine only

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Khalaf Elsayed

Resident, Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Sohag University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed K Elsayed, resident

Role: CONTACT

01112536649

Abdel Rahman H Abdel Rahman, professor

Role: CONTACT

01120320258

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 34801917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31030630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36670331 (View on PubMed)

Other Identifiers

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Soh-Med--25-3-06MS

Identifier Type: -

Identifier Source: org_study_id

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