A Pharmacokinetic Study of Sugammadex in Dialysis Patients

NCT04556721 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: STUDY19090331
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Disease

Keywords

Sugammadex; Bridion; hemodialysis; renal disease; rocuronium; Sugammadex-Rocuronium complex

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Number of participants experiencing any number of AEs deemed related to sugammadex drug

  Day of surgery through up to post-operative day 10

Study Arms (1)

Sugammadex

EXPERIMENTAL

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).

Drug: Sugammadex

Interventions

Sugammadex DRUG

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.

Also known as: Bridion

Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tetsuro Sakai: lead

Study Sites (1)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Tetsuro Sakai, MD, PhD, MHA

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: September 21, 2020
• Study Start: September 10, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)