A Single Center, Open-Label Trial in Subjects With Severe Renal Impairment Evaluating the Dialysability of the Sugammadex-Rocuronium Complex
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Rate of Clearance of Rocuronium From Blood
研究概览
简要总结
The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.
详细描述
The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •American Society of Anesthesiologists (ASA) Class >=4
- •Creatinine clearance (CLCR) < 30 mL/min and clinical indication for dialysis
- •Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium
- •Scheduled for a (surgical) procedure in supine position
- •Written informed consent (of the legal representative)
排除标准
- •Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction
- •Known or suspected to have a (family) history of malignant hyperthermia
- •Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- •Have already participated in a sugammadex trial
- •Have participated in another clinical trial, not preapproved by NV Organon, within 30 days of study entry
- •Females who are pregnant*
- •Females who are breast-feeding * In females pregnancy will be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
研究组 & 干预措施
Sugammadex
IV single bolus dose of 4.0 mg/kg sugammadex
干预措施: sugammadex (Drug)
Sugammadex
IV single bolus dose of 4.0 mg/kg sugammadex
干预措施: Rocuronium (Drug)
结局指标
主要结局
Rate of Clearance of Rocuronium From Blood
时间窗: Up to Day 7
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.
Rate of Clearance of Sugammadex From Blood
时间窗: Up to day 7
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.
Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)
时间窗: Up to day 7
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.
Rate of Clearance of Sugammadex From Dialysate
时间窗: Up to day 7
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable.
Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR)
时间窗: Up to Day 7
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.
Rate of Clearance of Rocuronium From Dialysate
时间窗: Up to Day 7
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.
次要结局
- Number of Participants With Pre-treatment Adverse Events (AEs)(Screening up to Day 1)
- Number of Participants With Serious Adverse Events (SAEs)(Up to day 7)
- Vital Sign: Mean Systolic Blood Pressure(Screening up to 1 day after surgery)
- Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium(Day 1)
- Number of Participants With Pregnancies at 30 Days Post-dose(Up to 30 days post -dose)
- Vital Sign: Mean Diastolic Blood Pressure(Screening up to 1 day after surgery)
- Vital Sign: Mean Heart Rate(Screening up to 1 day after surgery)
- Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8(Day 1)
- Number of Participants With Medical Device (Near) Incidents(Up to day 7)
- Number of Participants With Physical Examinations(Screening up to day 7)
- Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1(Day 1)
- Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7(Day 1)
- Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9(Day 1)