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

NCT ID: NCT04586790

Last Updated: 2020-10-14

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-01-28

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal 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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midodrine group

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

Group Type EXPERIMENTAL

Midodrine Oral Tablet

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Minirin oral tablet

Intervention Type DRUG

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

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 .

Group Type EXPERIMENTAL

Nor-Adrenaline

Intervention Type DRUG

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 .

Interventions

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Midodrine Oral Tablet

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

Minirin oral tablet

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

Nor-Adrenaline

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 .

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahmed talaat ahmed aly

OTHER

Sponsor Role lead

Responsible Party

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Ahmed talaat ahmed aly

clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed T Ahmed, lecture

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Ahmed Talaat Ahmed

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed T Ahmed, lecture

Role: CONTACT

01062716629

Amal A Mohamed

Role: CONTACT

0102 175 9992

Facility Contacts

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Amal A Mohamed

Role: primary

0102 175 9992

Ahmed T Ahmed, lecture

Role: backup

01062716629

Other Identifiers

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oral vasopressors

Identifier Type: -

Identifier Source: org_study_id

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