Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570187
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dexmedetomidines 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 hearts 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
1 What is dexmedetomidines 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 hearts 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
Detailed Description:
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
1 Assessment of dexmedetomidine effect in SA-AKI through following serum creatinine SCr level urinary output UOP and the need for renal replacement therapy RRT
2 Assessment of dexmedetomidine safety in SA-AKI through following the incidence of new-onset bradycardia and hypotension requiring intervention
3 Assessment of dexmedetomidine efficacy by determining the effect on hospital mortality duration of mechanical ventilation MV days free of agitation incidence of organ dysfunction other than AKI and length of hospital and ICU stay
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 05272 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 005 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 1263µmolL 276 in day 1 vs 1323 µmolL 264 in day 3 in the control group vs 1132 µmolL 289 in day 1 vs 1043 µmolL 221 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 005 will be considered statistically significant in all analyses
Aim of the study Evaluation of the effect of dexmedetomidine in Sepsis-Associated Acute Kidney Injury SA-AKI
Objectives
1 Assessment of dexmedetomidine effect in SA-AKI through following serum creatinine SCr level urinary output UOP and the need for renal replacement therapy RRT
2 Assessment of dexmedetomidine safety in SA-AKI through following the incidence of new-onset bradycardia and hypotension requiring intervention
3 Assessment of dexmedetomidine efficacy by determining the effect on hospital mortality duration of mechanical ventilation MV days free of agitation incidence of organ dysfunction other than AKI and length of hospital and ICU stay
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 05272 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 005 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 1263µmolL 276 in day 1 vs 1323 µmolL 264 in day 3 in the control group vs 1132 µmolL 289 in day 1 vs 1043 µmolL 221 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 005 will be considered statistically significant in all analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None