Back to resultsA Pharmacokinetic Study of Sugammadex in Dialysis Patients
Primary Purpose
Renal Disease
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
Sponsored by
About this trial
This is an interventional treatment trial for Renal Disease focused on measuring Sugammadex, Bridion, hemodialysis, renal disease, rocuronium, Sugammadex-Rocuronium complex
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
Sites / Locations
- UPMC Montefiore Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sugammadex
Arm Description
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).
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04556721
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty and lack of recruitment of the patients
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tetsuro Sakai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Disease
Keywords
Sugammadex, Bridion, hemodialysis, renal disease, rocuronium, Sugammadex-Rocuronium complex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma sugammadex concentration change from day of surgery to postoperative day 1 or 2 dialysis session
Description
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Time Frame
Day of surgery and postoperative day 1 or 2 dialysis session
Title
Plasma sugammadex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session
Description
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Time Frame
Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session
Title
Plasma sugammadex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Description
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Time Frame
Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Title
Plasma sugammadex-rocuronium complex concentration change from day of surgery and postoperative day 1 or 2 dialysis session
Description
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Time Frame
Day of surgery and postoperative day 1 or 2 dialysis session
Title
Plasma sugammadex-rocuronium complex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session
Description
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Time Frame
Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session
Title
Plasma sugammadex-rocuronium complex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Description
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Time Frame
Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Secondary Outcome Measure Information:
Title
Number of participants experiencing any number of AEs deemed related to sugammadex drug
Description
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.
Time Frame
Day of surgery through up to post-operative day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tetsuro Sakai, MD, PhD, MHA
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Montefiore Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pharmacokinetic Study of Sugammadex in Dialysis Patients
We'll reach out to this number within 24 hrs