Back to resultsProspective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs. (PROMISE)
Primary Purpose
Dexmedetomidine, Midazolam, Withdrawal Symptoms
Status
Recruiting
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Dexmedetomidine focused on measuring Dexmedetomidine, Midazolam, Intubation, Withdrawal Symptoms, failure of Extubating
Eligibility Criteria
Inclusion Criteria:
- Age 1-14 years both male and female who require mechanical ventilation
- Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
- Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours
Exclusion Criteria:
- Septic shock and/or multi-organ failure.
- Hemodynamically instability and requires inotropes.
- Severe intracranial or spinal trauma with high intracranial pressure
- Liver failure
- Acute or chronic renal failure.
- Glasgow Coma Scale (GCS) ≤8
- Known to have allergy to the study drugs
- Airway surgery
Sites / Locations
- King Abdullah Specialist Children Hospital (KASCH)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexmedetomidine (D)
Midazolam (M)
Arm Description
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.
Outcomes
Primary Outcome Measures
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
Secondary Outcome Measures
To compare length of PICU stay in both groups
Full Information
NCT ID
NCT05485519
First Posted
June 30, 2022
Last Updated
April 26, 2023
Sponsor
King Abdullah International Medical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT05485519
Brief Title
Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.
Acronym
PROMISE
Official Title
Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit (PICU) at KASCH-MNGHA.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.
Detailed Description
Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Midazolam, Withdrawal Symptoms, Failure of Extubation
Keywords
Dexmedetomidine, Midazolam, Intubation, Withdrawal Symptoms, failure of Extubating
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine (D)
Arm Type
Experimental
Arm Description
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Arm Title
Midazolam (M)
Arm Type
Active Comparator
Arm Description
1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
(1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute.
Primary Outcome Measure Information:
Title
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
Time Frame
from end of sedation to extubation assessed up to 24 hrs
Secondary Outcome Measure Information:
Title
To compare length of PICU stay in both groups
Time Frame
from Intubation to discharge assessed up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 1-14 years both male and female who require mechanical ventilation
Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours
Exclusion Criteria:
Septic shock and/or multi-organ failure.
Hemodynamically instability and requires inotropes.
Severe intracranial or spinal trauma with high intracranial pressure
Liver failure
Acute or chronic renal failure.
Glasgow Coma Scale (GCS) ≤8
Known to have allergy to the study drugs
Airway surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Majed A Jeraisy
Phone
+966-504192291
Ext
94455
Email
jjeraisym@ngha.med.sa
Facility Information:
Facility Name
King Abdullah Specialist Children Hospital (KASCH)
City
Riyadh
ZIP/Postal Code
14611
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Majed Jeraisy
Phone
0504192291
Email
JeraisyM@MNGHA.MED.SA
First Name & Middle Initial & Last Name & Degree
Majed A Jeraisy
12. IPD Sharing Statement
Learn more about this trial
Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.
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