A Pharmacokinetic Study of Sugammadex in Dialysis Patients

Phase 1

Withdrawn

• Conditions: Renal Disease
• Interventions: Drug: Sugammadex

• Registration Number: NCT04556721
• Lead Sponsor: Tetsuro Sakai

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Status Verified: 2021-09
• Study Start: 2021-09-10
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants experiencing any number of AEs deemed related to sugammadex drug	Day of surgery through up to post-operative day 10	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.

Trial Locations

Locations (1)

UPMC Montefiore Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States