Clinical trial NCT00656799: Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)
Official title: A Single Center, Open-Label Trial in Subjects With Severe Renal Impairment Evaluating the Dialysability of the Sugammadex-Rocuronium Complex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuromuscular Blockade
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-04-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)
timeFrame: Up to day 7
measure: Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR)
timeFrame: Up to Day 7
measure: Rate of Clearance of Sugammadex From Blood
timeFrame: Up to day 7
measure: Rate of Clearance of Rocuronium From Blood
timeFrame: Up to Day 7
measure: Rate of Clearance of Sugammadex From Dialysate
timeFrame: Up to day 7
measure: Rate of Clearance of Rocuronium From Dialysate
timeFrame: Up to Day 7
Secondary outcomes:
measure: Number of Participants With Pre-treatment Adverse Events (AEs)
timeFrame: Screening up to Day 1
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to day 7
measure: Number of Participants With Medical Device (Near) Incidents
timeFrame: Up to day 7
measure: Vital Sign: Mean Systolic Blood Pressure
timeFrame: Screening up to 1 day after surgery
measure: Vital Sign: Mean Diastolic Blood Pressure
timeFrame: Screening up to 1 day after surgery
measure: Vital Sign: Mean Heart Rate
timeFrame: Screening up to 1 day after surgery
measure: Number of Participants With Physical Examinations
timeFrame: Screening up to day 7
measure: Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1
timeFrame: Day 1
measure: Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium
timeFrame: Day 1
measure: Number of Participants With Pregnancies at 30 Days Post-dose
timeFrame: Up to 30 days post -dose
measure: Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9
timeFrame: Day 1
measure: Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8
timeFrame: Day 1
measure: Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
citation: Cammu G, Van Vlem B, van den Heuvel M, Stet L, el Galta R, Eloot S, Demeyer I. Dialysability of sugammadex and its complex with rocuronium in intensive care patients with severe renal impairment. Br J Anaesth. 2012 Sep;109(3):382-90. doi: 10.1093/bja/aes207. Epub 2012 Jun 24.