Clinical trial NCT04556721: A Pharmacokinetic Study of Sugammadex in Dialysis Patients
Official title: Assessing the Post-Surgical Trend of Sugammadex Concentration in Dialysis Dependent Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Renal Disease
Keywords: Sugammadex
Bridion
hemodialysis
renal disease
rocuronium
Sugammadex-Rocuronium complex
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma sugammadex concentration change from day of surgery to postoperative day 1 or 2 dialysis session
timeFrame: Day of surgery and postoperative day 1 or 2 dialysis session
measure: Plasma sugammadex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session
timeFrame: Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session
measure: Plasma sugammadex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
timeFrame: Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
measure: Plasma sugammadex-rocuronium complex concentration change from day of surgery and postoperative day 1 or 2 dialysis session
timeFrame: Day of surgery and postoperative day 1 or 2 dialysis session
measure: Plasma sugammadex-rocuronium complex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session
timeFrame: Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session
measure: Plasma sugammadex-rocuronium complex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
timeFrame: Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Secondary outcomes:
measure: Number of participants experiencing any number of AEs deemed related to sugammadex drug
timeFrame: Day of surgery through up to post-operative day 10
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Montefiore Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Tetsuro Sakai, MD, PhD, MHA
role: PRINCIPAL_INVESTIGATOR
References: