Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-29 @ 9:38 PM
Study NCT ID:
NCT06930235
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Midodrine as an Adjuvant to Norepinephrine in Weaning Critically Ill Patients From Vasopressors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'follow up of critically ill patients on vasopressors', 'timeFrame': '48 hours', 'description': 'time of weaning from intravenous vasopressor (norepinephrine)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shock']}, 'referencesModule': {'references': [{'pmid': '34801917', 'type': 'BACKGROUND', 'citation': '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': '31030630', 'type': 'BACKGROUND', 'citation': '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': '36670331', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of midodrine as an adjuvant to norepinephrine in weaning critically ill patients from vasopressors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with refractory hypotension on an intravenous vasopressor for more than 24 h but deemed clinically stable.\n* Patients on noradrenaline support \\<10 μg/min\n\nExclusion Criteria:\n\n* Known allergy to midodrine.\n* Severe shock state, as evidenced by multiple vasopressor infusions or high vasopressor requirement (i.e. noradrenaline \\>10 μg/min)\n* Patients with severe organic heart disease (e.g., heart failure, sever aortic stenosis), pregnancy, thyrotoxicosis or pheochromocytoma.\n* Those with no enteral route available.'}, 'identificationModule': {'nctId': 'NCT06930235', 'briefTitle': 'Effectiveness of Midodrine as an Adjuvant to Norepinephrine in Weaning Critically Ill Patients From Vasopressors', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Effectiveness of Midodrine as an Adjuvant to Norepinephrine in Weaning Critically Ill Patients From Vasopressors', 'orgStudyIdInfo': {'id': 'Soh-Med--25-3-06MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Weaning critically ill patients from norepinephrine using midodrine as an adjuvant to norepinephrine', '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.', 'interventionNames': ['Drug: Weaning critically ill patients from norepinephrine using midodrine as an adjuvant to norepinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weaning critically ill patients from norepinephrine without use of midodrine as an adjuvant', 'description': 'Patients in group II with ongoing intravenous norepinephrine only', 'interventionNames': ['Drug: Weaning critically ill patients from norepinephrine without use of midodrine as an adjuvant']}], 'interventions': [{'name': 'Weaning critically ill patients from norepinephrine using midodrine as an adjuvant to norepinephrine', 'type': 'DRUG', '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 hrs.', 'armGroupLabels': ['Weaning critically ill patients from norepinephrine using midodrine as an adjuvant to norepinephrine']}, {'name': 'Weaning critically ill patients from norepinephrine without use of midodrine as an adjuvant', 'type': 'DRUG', 'description': 'Patients in group II with ongoing intravenous norepinephrine only', 'armGroupLabels': ['Weaning critically ill patients from norepinephrine without use of midodrine as an adjuvant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohammed K Elsayed, resident', 'role': 'CONTACT', 'email': 'mohammed.khalaf1718@gmail.com', 'phone': '01112536649'}, {'name': 'Abdel Rahman H Abdel Rahman, professor', 'role': 'CONTACT', 'phone': '01120320258'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident, Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Sohag University', 'investigatorFullName': 'Mohamed Khalaf Elsayed', 'investigatorAffiliation': 'Sohag University'}}}}