the Effect of Oral Vasopressors for Liberation From IV Vasopressors in Spinal Shock
The Effect of Oral Midodrine Versus Oral Desmopressin Acetate Use for Liberation From IV Noradrenaline in Intensive Care Unit Patients Recovering From Spinal Shock .
1 other identifier
interventional
90
1 country
1
Brief Summary
the study is developed to evaluate the effect of use of oral vasopressors (midodrine versus minirin) on weaning ICU patients from IV vasopressors (noradrenaline) and compare between them for efficacy in shortage the duration of IV vasopressor and has low complications and side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2021
CompletedOctober 14, 2020
October 1, 2020
3 months
October 7, 2020
October 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
liberation the patient from IV vasopressors with maintaining hemodynamics.
Blood pressure will be assessed regularly every 15 minutes
48 hrs
Study Arms (3)
midodrine group
EXPERIMENTALmidodrine group will receive midodrine 10 mg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral midodrine
minirin group
EXPERIMENTALthe patients will receive minirin 60 µg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral minirin
control group
EXPERIMENTALthe patients will receive IV nor-adrenaline and are gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin .
Interventions
midodrine group will receive midodrine 10 mg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral midodrine .
Minirin group will receive minirin 60 µg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral minirin .
control group will receive IV nor-adrenaline and is gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin .
Eligibility Criteria
You may qualify if:
- Age of 18 - 60 years.
- Patients of both genders.
- Patients diagnosed by spinal shock and they are in the recovery stage .
You may not qualify if:
- Patient refusal.
- Anuric or oliguric patients or patients with chronic kidney disease.
- Patients with allergy to medication included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmed Talaat Ahmed
Asyut, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed T Ahmed, lecture
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 14, 2020
Study Start
October 15, 2020
Primary Completion
January 1, 2021
Study Completion
January 28, 2021
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share