A Pharmacokinetic Study of Sugammadex in Dialysis Patients

NCT ID: NCT04556721

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2021-09-10

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.

Conditions

Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sugammadex

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).

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Bridion

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tetsuro Sakai

OTHER

Sponsor Role: lead

Responsible Party

Tetsuro Sakai

Professor, Anesthesiology and Perioperative Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tetsuro Sakai, MD, PhD, MHA

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19090331

Identifier Type: -

Identifier Source: org_study_id