The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients
NCT06570187 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2024-10-09
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.
Conditions
- Sepsis
- Septic Shock
- Acute Kidney Injury
Interventions
- DRUG
-
Dexmedetomidine
Dexmedetomidine will be administered with an initial dose of 0.2 μg/kg/hour, infusion rate is to be titrated based on response for at least 24 hours.
- DRUG
-
Propofol
Propofol will be administered as the comparator sedative with the standard treatment of sepsis and septic shock.
Sponsors & Collaborators
-
Cairo University
lead OTHER
Principal Investigators
-
Nirmeen A Sabry, Ph.D · Cairo University
-
Amany M Mohamed, Ph.D · Cairo University
-
Ramadan M Khalil, MD · Cairo University
-
Kanzy M Hassan, B. Pharm · Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-01
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
Countries
- Egypt
Study Locations
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