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NCT05903963 Clinical Trial

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

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05903963
Other study ID # 335-2022
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 22, 2023
Est. completion date December 20, 2023

Study information
Verified date June 2023
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 20, 2023
Est. primary completion date November 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Marlin Zarif Shehata Minya

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of acute kidney injury urinary kidney injury molecule 5 days
Secondary length of ICU stay days of ICU stay 10 days
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