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the Effect of Oral Vasopressors for Liberation From IV Vasopressors in Spinal Shock

Primary Purpose

Spinal Shock

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Midodrine Oral Tablet
Minirin oral tablet
Nor-Adrenaline
Sponsored by
Ahmed talaat ahmed aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Shock

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of 18 - 60 years.
  • Patients of both genders.
  • Patients diagnosed by spinal shock and they are in the recovery stage .

Exclusion Criteria:

  • Patient refusal.
  • Anuric or oliguric patients or patients with chronic kidney disease.
  • Patients with allergy to medication included in the study.

Sites / Locations

  • Ahmed Talaat AhmedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

midodrine group

minirin group

control group

Arm Description

midodrine group will receive midodrine 10 mg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral midodrine

the patients will receive minirin 60 µg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral minirin

the patients will receive IV nor-adrenaline and are gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin .

Outcomes

Primary Outcome Measures

liberation the patient from IV vasopressors with maintaining hemodynamics.
Blood pressure will be assessed regularly every 15 minutes

Secondary Outcome Measures

Full Information

First Posted
October 7, 2020
Last Updated
October 7, 2020
Sponsor
Ahmed talaat ahmed aly
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1. Study Identification

Unique Protocol Identification Number
NCT04586790
Brief Title
the Effect of Oral Vasopressors for Liberation From IV Vasopressors in Spinal Shock
Official Title
The Effect of Oral Midodrine Versus Oral Desmopressin Acetate Use for Liberation From IV Noradrenaline in Intensive Care Unit Patients Recovering From Spinal Shock .
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed talaat ahmed aly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
midodrine group
Arm Type
Experimental
Arm Description
midodrine group will receive midodrine 10 mg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral midodrine
Arm Title
minirin group
Arm Type
Experimental
Arm Description
the patients will receive minirin 60 µg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral minirin
Arm Title
control group
Arm Type
Experimental
Arm Description
the patients will receive IV nor-adrenaline and are gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin .
Intervention Type
Drug
Intervention Name(s)
Midodrine Oral Tablet
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Minirin oral tablet
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Nor-Adrenaline
Intervention Description
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 .
Primary Outcome Measure Information:
Title
liberation the patient from IV vasopressors with maintaining hemodynamics.
Description
Blood pressure will be assessed regularly every 15 minutes
Time Frame
48 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18 - 60 years. Patients of both genders. Patients diagnosed by spinal shock and they are in the recovery stage . Exclusion Criteria: Patient refusal. Anuric or oliguric patients or patients with chronic kidney disease. Patients with allergy to medication included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed T Ahmed, lecture
Phone
01062716629
Email
Ahmedtalaat_ahmed@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amal A Mohamed
Phone
0102 175 9992
Email
amalabdelnasser28@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed T Ahmed, lecture
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Talaat Ahmed
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal A Mohamed
Phone
0102 175 9992
Email
amalabdelnasser28@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed T Ahmed, lecture
Phone
01062716629
Email
Ahmedtalaat_ahmed@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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the Effect of Oral Vasopressors for Liberation From IV Vasopressors in Spinal Shock

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