NCT06570187 The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients
| NCT ID | NCT06570187 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cairo University |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 128 participants in total. It began in 2024-10-01 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Nirmeen A Sabry, Ph.D
STUDY CHAIR
Cairo University
Frequently Asked Questions
Who can join the NCT06570187 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06570187 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06570187 currently recruiting?
Yes, NCT06570187 is actively recruiting participants. Contact the research team at kanzy.mostafa.hassan@std.pharma.cu.edu.eg for enrollment information.
Where is the NCT06570187 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06570187 clinical trial?
NCT06570187 is sponsored by Cairo University. The principal investigator is Nirmeen A Sabry, Ph.D at Cairo University. The trial plans to enroll 128 participants.