NCT05903963

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

May 30, 2023

Last Update Submit

June 10, 2023

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute kidney injury

    urinary kidney injury molecule

    5 days

Secondary Outcomes (1)

  • length of ICU stay

    10 days

Study Arms (2)

Midazolam group

ACTIVE COMPARATOR
Drug: Midazolam

dexmedetomidine group

ACTIVE COMPARATOR
Drug: dexmedetomidine

Interventions

MidazolamDRUG

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.

Midazolam group
dexmedetomidineDRUG

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

dexmedetomidine group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age (18-80) years old. sex:both male and female.
  • intubated and mechanically ventilated patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marlin Zarif Shehata

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

MidazolamDexmedetomidine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. lecturer of anesthesia and pain medicine

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 15, 2023

Study Start

May 22, 2023

Primary Completion

November 12, 2023

Study Completion

December 20, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

EG(1)