The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients
NCT Number: NCT06570187
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Sepsis|Septic Shock|Acute Kidney Injury
Interventions: DRUG: Dexmedetomidine|DRUG: Propofol
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2026-10
Locations: Cairo University, Cairo, Egypt

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.

Primary Outcome Measures: Change in serum creatinine (SCr), Reduction in SCr ≥ 0.3 mg/dL within ≤ 72 hours. For patients known as acute on top of chronic kidney disease (CKD), decrease in SCr to \< 1.5 times the baseline, Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
Secondary Outcome Measures: Incidence of Renal Replacement therapy (RRT), Incidence of requiring RRT during hospitalization, Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks|Change in Sequential Organ Failure Assessment (SOFA)., Change in SOFA from baseline, Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks|Incidence of agitation, Number of days free of agitation using Richmond Agitation and Sedation Scale (RASS) (0) to (-2)., Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks|Incidence of bradycardia, Incidence of new onset symptomatic bradycardia (defined as heart rate \< 50 beats per minutes requiring intervention e.g. pacing, pharmacological support, or modification of dexmedetomidine)., Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks|Incidence of hypotension, Incidence of hypotension requiring an intervention (fluid administration and/or vasopressor therapy, or dose modification if the patient was already on a vasopressor)., Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks|Duration on mechanical ventilation, Number of days on mechanical ventilation, Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks|Length of hospital and ICU stay, Number of days of hospitalization, Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks|Incidence of another organ dysfunction, Incidence of organ dysfunction other than AKI (defined as: Coagulation, platelet count \< 100,000/mm3; Hepatic, total bilirubin \> 2 mg/dL; Respiratory, ration between oxygen saturation and fractional inspired oxygen SaO2/FiO2 \< 315), Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks|In-hospital mortality, Incidence of death, From time of enrolment until date of death, assessed up to 1 month