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NCT Number: NCT06570187

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

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.

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Key information

Conditions

Sepsis Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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:

  • Assessment of dexmedetomidine effect in SA-AKI through following serum creatinine (SCr) level, urinary output (UOP), and the need for renal replacement therapy (RRT).
  • Assessment of dexmedetomidine safety in SA-AKI through following the incidence of new-onset bradycardia, and hypotension requiring intervention.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Drug

Propofol will be administered as the comparator sedative with the standard treatment of sepsis and septic shock.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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).

  5. 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).

  6. 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

  7. 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

  8. 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)

  9. In-hospital mortality

    Time frame: From time of enrolment until date of death, assessed up to 1 month

    Incidence of death

Study contacts

Contact information is provided by the study sponsor or research team.

Kanzy Hassan, B. Pharm

CONTACT

[email protected]

+201550793228

Nirmeen A Sabry, Ph.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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