The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients

October 5, 2024 updated by: Kanzy Mostafa Hassan, Cairo University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
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
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.
Active Comparator: Control
Participants will receive the standard sepsis and septic shock treatment and the standard sedatives without dexmedetomidine.
Drug: Propofol
Propofol will be administered as the comparator sedative with the standard treatment of sepsis and septic shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum creatinine (SCr)
Time Frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
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

Outcome Measure
Measure Description
Time Frame
Incidence of Renal Replacement therapy (RRT)
Time Frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
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).
Time Frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
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
Time Frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
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
Time Frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
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
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 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
Time Frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
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
Time Frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
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
Time Frame: Assessment will be done at time of randomization then every 48 hours through hospitalization stay, an average of 2 weeks
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
Time Frame: From time of enrolment until date of death, assessed up to 1 month
Incidence of death
From time of enrolment until date of death, assessed up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Nirmeen A Sabry, Ph.D, Cairo university
  • Study Director: Amany M Mohamed, Ph.D, Cairo university
  • Study Director: Ramadan M Khalil, MD, Cairo university
  • Principal Investigator: Kanzy M Hassan, B. Pharm, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 5, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL (3635)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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