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

Sponsor

Minia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05903963

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Failure	Drug: Midazolam Drug: dexmedetomidine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 22, 2023

Anticipated Primary Completion Date :

Nov 12, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Midazolam group	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.
Active Comparator: dexmedetomidine group	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 .

Arm

Intervention/Treatment

Active Comparator: Midazolam group

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.

Active Comparator: dexmedetomidine group

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 .

Outcome Measures

Primary Outcome Measures

Incidence of acute kidney injury [5 days]
urinary kidney injury molecule

Secondary Outcome Measures

length of ICU stay [10 days]
days of ICU stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

pregnancy or lactation. 5. serious central nervous system pathology (acute stroke, uncontrolled seizures, severe dementia).
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marlin Zarif Shehata	Minya		Egypt

Sponsors and Collaborators

Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marlin Zarif Shehata Yousef, Ass. lecturer of anesthesia and pain medicine, Minia University

ClinicalTrials.gov Identifier:

NCT05903963

Other Study ID Numbers:

335-2022

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Midazolam

Dexmedetomidine

Study Results

No Results Posted as of Jun 15, 2023