Back to resultsEvaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit
Primary Purpose
Renal Failure
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Midazolam
dexmedetomidine
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Failure
Eligibility Criteria
Inclusion Criteria: Age (18-80) years old. sex:both male and female. intubated and mechanically ventilated patients. Exclusion Criteria: 1.Patient's relatives refusal. 2. burns as admitting diagnoses. 3.patients with any renal pathology(such as chronic glomerulonephritis, pyelonephritis and diabetic nephropathy). 4. pregnancy or lactation. 5. serious central nervous system pathology (acute stroke, uncontrolled seizures, severe dementia). 6. acute hepatitis or severe liver disease (Child-Pugh class C). 7. unstable angina or acute myocardial infarction, left ventricular ejection fraction less than 30%, heart rate less than 50/min, second- or third-degree heart block, or systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.
Sites / Locations
- Marlin Zarif ShehataRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Midazolam group
dexmedetomidine group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of acute kidney injury
urinary kidney injury molecule
Secondary Outcome Measures
length of ICU stay
days of ICU stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05903963
Brief Title
Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit
Official Title
Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
November 12, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Midazolam group
Arm Type
Active Comparator
Arm Title
dexmedetomidine group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
midazolam infusion by 0.03-0.3mg/kg in increments of 1-2.5mg followed by Maintenance dose: 0.03-0.2mg/kg/hour for midazolam.
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
dexmedetomidine infusion 1 µg/kg dexmedetomidine for 10 minutes followed by a continuous IV infusion at 0.2-0.3 µg/kg/hour .
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury
Description
urinary kidney injury molecule
Time Frame
5 days
Secondary Outcome Measure Information:
Title
length of ICU stay
Description
days of ICU stay
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age (18-80) years old. sex:both male and female.
intubated and mechanically ventilated patients.
Exclusion Criteria:
1.Patient's relatives refusal. 2. burns as admitting diagnoses. 3.patients with any renal pathology(such as chronic glomerulonephritis, pyelonephritis and diabetic nephropathy).
4. pregnancy or lactation. 5. serious central nervous system pathology (acute stroke, uncontrolled seizures, severe dementia).
6. acute hepatitis or severe liver disease (Child-Pugh class C). 7. unstable angina or acute myocardial infarction, left ventricular ejection fraction less than 30%, heart rate less than 50/min, second- or third-degree heart block, or systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.
Facility Information:
Facility Name
Marlin Zarif Shehata
City
Minya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlin shehata
Phone
02-01015752424
Email
marlin27zarif@gmail.com
12. IPD Sharing Statement
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Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit
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