Evaluating dexmedetomidine's effects on kidney function in critically ill patients with sepsis
The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients
This study is testing if dexmedetomidine can help improve kidney function in critically ill patients with sepsis-related kidney problems compared to a standard sedative.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06570187 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of dexmedetomidine on renal function in critically ill patients suffering from sepsis-associated acute kidney injury (SA-AKI). Participants will be randomly assigned to receive either dexmedetomidine or a standard sedative during their ICU stay, with careful monitoring of vital signs, laboratory data, and overall organ function. The study aims to assess both the safety and efficacy of dexmedetomidine, focusing on kidney function, hospital mortality, and duration of mechanical ventilation. The trial will include 128 participants and will be conducted at Cairo University Hospitals.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 years old who develop acute kidney injury due to sepsis within 48 hours of ICU admission and require sedation for mechanical ventilation.
Not a fit: Patients with severe bradycardia, active myocardial ischemia, or other significant contraindications to dexmedetomidine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney function and reduced mortality in critically ill patients with sepsis.
How similar studies have performed: While dexmedetomidine has shown promise in organ protection, this specific application in sepsis-associated acute kidney injury is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Kanzy M Hassan, B. Pharm — Cairo University
- Study coordinator: Kanzy Hassan, B. Pharm
- Email: kanzy.mostafa.hassan@std.pharma.cu.edu.eg
- Phone: +201550793228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.