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

Recruiting now · Phase 4

Conditions studied: Sepsis, Septic Shock, Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT06570187

Run by

Cairo University

People needed

128

Starts

2024-10-01

Expected to finish

2026-10-01

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >21 years old
• Patients with sepsis who develop AKI within 48 hours during ICU stay
• Need for sedation due to the need for mechanical ventilation (MV) (both invasive and non- invasive) within 48 hours of AKI

You may not qualify if…

• Contraindications to dexmedetomidine including any of the following: severe bradycardia (heart rate (HR) < 50 beats/min), sick sinus syndrome or second-to-third degree atrioventricular block unless a pacemaker is inserted
• Acute myocardial ischemia
• Mean arterial blood pressure < 50 mmHg despite adequate resuscitation and vasopressor therapy at the time of enrollment
• Pregnancy or lactation
• Duration of dexmedetomidine infusion < 24 hours
• Severe valvular heart disease
• Active seizures during this ICU admission requiring benzodiazepines
• Proven or suspected traumatic brain injury, intracranial hemorrhage, stroke, or spinal cord injury

Where it is running

• Cairo University — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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