Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit

NCT ID: NCT05903963

Last Updated: 2023-06-15

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

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2023-12-20

Brief Summary

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Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit

Detailed Description

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Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Midazolam group

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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.

dexmedetomidine group

Group Type ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type DRUG

dexmedetomidine infusion 1 µg/kg dexmedetomidine for 10 minutes followed by a continuous IV infusion at 0.2-0.3 µg/kg/hour .

Interventions

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Midazolam

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

dexmedetomidine

dexmedetomidine infusion 1 µg/kg dexmedetomidine for 10 minutes followed by a continuous IV infusion at 0.2-0.3 µg/kg/hour .

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Marlin Zarif Shehata Yousef

Ass. lecturer of anesthesia and pain medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marlin Zarif Shehata

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Marlin shehata

Role: primary

02-01015752424

Other Identifiers

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335-2022

Identifier Type: -

Identifier Source: org_study_id

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