A Phase 4 interventional study of Dexmedetomidine and Propofol in Sepsis, Septic Shock and Acute Kidney Injury, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Cairo University · Phase 4, Interventional, and Supportive care
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:
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:
Recently, it has been confirmed that dexmedetomidine has an organ protective effect, including the nervous system, heart, lungs, kidneys, liver, and small intestine. These properties allow dexmedetomidine to be a promising candidate for clinical multiorgan protection.
Aim of the study: Evaluation of the effect of dexmedetomidine in Sepsis-Associated Acute Kidney Injury (SA-AKI).
Objectives:
Study Design:
The study will be a prospective, randomized, parallel, controlled, open-label clinical trial including 128 participants with SA-AKI. Participants will be recruited from the Critical Care Department at Cairo University Hospitals. Randomization will be carried out using Random Allocation Software. Patients will be randomly allocated into two groups after screening for inclusion and exclusion criteria.
Written informed consent will be obtained from participants' legal caregivers.
Ethical committee approval will be available.
The primary investigator will be responsible for data collection. Each participant will be presented using a sequential number.
Participants recruitment and concealment allocation, data collection, data management, and data analysis will all be subjected to supervision and on-site auditing by academic and medical supervisors. For data verification, medical records revision will be done, to ensure the accuracy and completeness of the collected data.
Based on the pattern and percentage of missing data, the study investigator is expecting either missing completely at random (MCAR) or missing at random (MAR). Accordingly, multiple imputation (MI) will be implemented to handle missing data.
Normal ranges for lab data will be available.
Study outcomes will be assessed every 48 hours.
Sample size calculation:
Sample size calculation was performed using G power software. The sample size was based on an effect size of 0.5272. A total sample size of 116 patients (58 patients per group) is needed to reject the null hypothesis of equality of means between the control and treatment groups with an 80% power at a 5% significance level (α = 0.05) using two tails t-test.
The effect size was calculated based on the difference in SCr between day 1 and day 3 in septic AKI patients (126.3µmol/L ± 27.6 in day 1 vs. 132.3 µmol/L ± 26.4 in day 3 in the control group vs. 113.2 µmol/L ± 28.9 in day 1 vs. 104.3 µmol/L ± 22.1 in day 3 in the dexmedetomidine group).
Including a dropout ratio of 10%, the final total sample size is 128 patients (64 patients per group).
Statistical analysis:
The collected data will be thoroughly revised, coded, and tabulated, followed by statistical analysis. Qualitative data will be presented as numbers and percentages. Quantitative data will be represented as mean and standard deviation (SD), or median and interquartile range (IQR) according to data distribution. Chi-square test will be used to compare groups regarding non-numerical variables. Independent samples t-test of significance will be used to compare two means.
To compare proportions between two qualitative characteristics, the Chi-square (x2) test of significance will be used.
A P-value of less than 0.05 will be considered statistically significant in all analyses.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's planned enrollment of 128 is above the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive the standard sepsis and septic shock treatment with dexmedetomidine, which is to be administered with an initial dose of 0.2 μg/kg/hour, and the infusion rate is to be titrated based on response for at least 24 hours.
Drug: Dexmedetomidine
Participants will receive the standard sepsis and septic shock treatment and the standard sedatives without dexmedetomidine.
Drug: Propofol
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.
Propofol will be administered as the comparator sedative with the standard treatment of sepsis and septic shock.
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
Time frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
Incidence of Renal Replacement therapy (RRT)
Incidence of requiring RRT during hospitalization
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: From time of enrolment until date of death, assessed up to 1 month
Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.
Of 48 non-industry phase 4 interventional studies under Sepsis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 51. This study's planned 24 months is below that.
Counting every sponsor, half of 49 studies reached it within 31 months; a quarter within 21 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Dexmedetomidine