Actively Recruiting

Phase 4
Age: 18Years - 90Years
All Genders
NCT06570187

The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients

Led by Cairo University · Updated on 2024-10-09

128

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial aims to evaluate the effect of dexmedetomidine in Sepsis-Associated Acute Kidney Injury in critically ill patients by answering the following questions: 1. What is dexmedetomidine's effect on kidney functions? 2. What is the safety and efficacy of dexmedetomidine in Sepsis-Associated Acute Kidney Injury? The investigator will compare dexmedetomidine to the standard sedative. The Participant will take either dexmedetomidine or the standard sedative during their hospitalization, with follow-up of the following: 1. Vital signs including blood pressure, body temperature, respiratory rate, heart rate, and oxygen saturation. 2. Laboratory data including kidney function tests, electrolytes, complete blood count, and liver function tests. 3. An electrocardiogram will be followed to check the heart's electrical activity. 4. The level of alertness or agitation to avoid over and under-sedation. 5. The level of organ dysfunction and mortality risks. 6. Duration of mechanical ventilation. 7. Duration of hospitalization.

CONDITIONS

Official Title

The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 21 years old
  • Patients with sepsis who develop acute kidney injury within 48 hours during ICU stay
  • Need for sedation due to mechanical ventilation (invasive or non-invasive) within 48 hours of acute kidney injury
Not Eligible

You will not qualify if you...

  • Severe bradycardia (heart rate less than 50 beats per minute), sick sinus syndrome, or second-to-third degree atrioventricular block unless a pacemaker is present
  • Acute myocardial ischemia
  • Mean arterial blood pressure less than 50 mmHg despite adequate resuscitation and vasopressor therapy at enrollment
  • Pregnancy or lactation
  • Duration of dexmedetomidine infusion less than 24 hours
  • Severe valvular heart disease
  • Active seizures during ICU admission requiring benzodiazepines
  • Proven or suspected traumatic brain injury, intracranial hemorrhage, stroke, or spinal cord injury

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

K

Kanzy Hassan, B. Pharm

CONTACT

N

Nirmeen A Sabry, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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