A Pharmacokinetic Study of Sugammadex in Dialysis Patients

Withdrawn before enrolling · Phase 1

Conditions studied: Renal Disease

In brief

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.

Key facts

Study ID

NCT04556721

Run by

Tetsuro Sakai

People needed

0

Starts

2021-09-10

Expected to finish

2021-09-10

Last updated by the study team

2021-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UPMC Montefiore Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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