A Pharmacokinetic Study of Sugammadex in Dialysis Patients

Study Overview
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Brief Summary
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The primary objective of this prospective study is to assess the trend of sugammadex (and its complex with rocuronium) concentration in surgical patients with routine outpatient hemodialysis. Patients with end stage renal disease who are to receive general anesthesia and muscle paralysis will have their paralysis by rocuronium reversed with sugammadex. Patients will then have blood drawn during their next three routine hemodialysis sessions to assess for the plasma concentration of sugammadex or the sugammadex-rocuronium complex over time.

Detailed Description
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Patients with end-stage renal disease often have several additional comorbidities and stand to benefit immensely from this established superior drug. Prior studies have not been able to correlate negative adverse events with sugammadex in patients with end-stage renal disease. More work needs to be done, however, to assess the fate of this renally excreted molecule. It has been shown that there is potential to clear sugammadex with high flux dialysis. We hypothesize that post-surgical patients with end-stage renal disease will see a significant decrease in plasma sugammadex concentration after routine outpatient dialysis.

Official Title
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Assessing the Post-Surgical Trend of Sugammadex Concentration in Dialysis Dependent Patients

Conditions
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Renal Disease

Intervention / Treatment
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* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Currently on hemodialysis renal replacement therapy To be undergoing a surgical procedure with the intent of starting hemodialysis postoperatively To be undergoing a surgical procedure requiring general anesthesia To have neuromuscular blockade for the surgical procedure Exclusion Criteria: Diagnosed with a blood-borne infection (Hepatitis B or C, HIV) Allergy to rocuronium or sugammadex Planned renal transplant procedure Peritoneal dialysis patient Starting hemoglobin value of less than 8.0 g/dl Women who are currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br>After surgery and general anesthesia, a clinically-appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade. Either 2 mg/kg or 4 mg/kg dosing will be used based on the level of neuromuscular blockade at the time of reversal. Administer as single IV bolus injection infused over 10 seconds into existing IV line. Dose is based on actual body weight (mg/kg). | Drug: Sugammadex<br>* On the day of surgery, after the establishment of general anesthesia, patients will be paralyzed via rocuronium. At the cessation of the case, an appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade.<br>* Other names: Bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma sugammadex concentration change from day of surgery to postoperative day 1 or 2 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). | Day of surgery and postoperative day 1 or 2 dialysis session | 
| Plasma sugammadex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). | Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session | 
| Plasma sugammadex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). | Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session | 
| Plasma sugammadex-rocuronium complex concentration change from day of surgery and postoperative day 1 or 2 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). | Day of surgery and postoperative day 1 or 2 dialysis session | 
| Plasma sugammadex-rocuronium complex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). | Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session | 
| Plasma sugammadex-rocuronium complex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). | Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing any number of AEs deemed related to sugammadex drug | Adverse events will be reviewed in the subject electronic medical records (EMR) and relation to the study drug will be determined by the investigator and recorded by research staff. Any untoward medical occurrence resulting from the study drug will be recorded. | Day of surgery through up to post-operative day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugammadex, Bridion, hemodialysis, renal disease, rocuronium, Sugammadex-Rocuronium complex