A Pharmacokinetic Study of Sugammadex in Dialysis Patients

Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04556721
• Other study ID #: STUDY19090331
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 10, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: September 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Disease

Intervention

Drug:
• Sugammadex
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.

Locations

Country	Name	City	State
United States	UPMC Montefiore Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tetsuro Sakai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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