A Phase 4 interventional study of cisatracurium in Critical Illness, Respiratory Distress Syndrome, Adult and Neuromuscular Blockade, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by Mahidol University · Phase 4, Interventional, and Basic science
Pathophysiological changes influenced by multiple factors in critically ill patients, has a significant impact on pharmacokinetics (PK) and pharmacodynamics (PD) of cisatracurium. In order to understand better and find an appropriate dosing regimen, the purpose of this study is to investigate the PK and PD of a loading dose cisatracurium in critically ill patients.
Cisatracurium, nondepolarizing neuromuscular blocking agents (NMBAs), are commonly used in intensive care units because of a lesser effect on hemodynamic parameters and a reduction in mortality rate in ARDS patients. Loading dose recommended in clinical practice guidelines for sustained neuromuscular blockade in the adult critically ill patient is 0.1-0.2 mg/kg. Then, maintenance dose of 1-3 mcg/kg/min is followed regarding indications, such as ARDS. However, this recommended loading dose might not be adequate in critically ill patients, the study in this specific population might be needed.
Neuromuscular blocking agents (NMBAs) are commonly used in critically ill patients, especially in adult respiratory distress syndrome (ARDS). Use of NMBAs to facilitate mechanical ventilation, to control patient/ventilator asynchrony and to reduce uncontrolled muscle tone in special conditions including tetanus, therapeutic hypothermia, and status epilepticus were increasingly found in current clinical practice.
Cisatracurium, 1Rcis-1'Rcis isomer of atracurium, is benzylisoquinolium nondepolarizing NMBAs which is three to five folds higher potency than atracurium besylate. The degradation of cisatracurium by hofmann elimination and ester hydrolysis in plasma generates laudanosine and a monoquaternary acrylate metabolite. Clinical practice guidelines for sustained neuromuscular blockade in the adult critically ill patient published in year 2016 strongly recommended cisatracurium due to a reduction in incidence of prolonged blockade, cardiovascular related adverse events and anaphylactic reactions. Moreover, recent evidence showed that early use of cisatracurium in early severe ARDS patients led to a significant reduction in mortality.
Regarding pharmacokinetics and pharmacodynamics of cisatracurium in critically ill patients, there were multiple factors affected cisatracurium blood concentration and neuromuscular blockade actions. Several reports demonstrated that pathophysiological changes, such as age, hypothermia/ hyperthermia, electrolyte imbalance and acid-base disturbances, had a significant impact on PK and PD of cisatracurium. Currently, there were an increasing data of slow response and less paralysis effect in critically ill patients receiving standard dose of cisatracurium. These may be explained by inadequate drug concentration at target organ, therefore, treatment failures regarding recommended dose of cisatracurium has been reported. Consequently, higher cisatracurium dose with higher drug concentration level might overcome a problem of inadequate level and therapeutic failure while receiving a standard dose of cisatracurium (a loading dose of 0.1-0.2 mg/kg, followed by a maintenance dose of 1-3 mcg/kg/min)
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
Compared within Respiratory Distress Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who require paralysis with cisatracurium as part of their clinical care in ICU
Drug: cisatracurium
A single dose of 0.2 mg/kg intravenous bolus cisatracurium will be administered and blood samples will be taken before and at least 7 occasions post dose (at 1, 5, 10, 12, 15, 20, 30, and/or 60 minutes after a single bolus).
Also known as: Nimbex
Total plasma concentration-time data
Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS.
Time frame: Pre-dose through 60 minutes post-dose
Patient-ventilator asynchrony - time data
Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS.
Time frame: Pre-dose through 60 minutes post-dose
The degree of neuromuscular block by train-of-four-watch monitor - time data
Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS.
Time frame: Pre-dose through 60 minutes post-dose
Time to maximum concentration
Analysis of time to maximum concentration will be performed with a nonlinear mixed-effects population modelling approach as implemented in NONMEM software.
Time frame: Pre-dose through 60 minutes post-dose
Half-life
Analysis of half-life will be performed with a nonlinear mixed-effects population modelling approach as implemented in NONMEM software.
Time frame: Pre-dose through 60 minutes post-dose
Clearance
Analysis of clearance will be performed with a nonlinear mixed-effects population modelling approach as implemented in NONMEM software.
Time frame: Pre-dose through 60 minutes post-dose
Elimination rate constant
Analysis of elimination rate constant will be performed with a nonlinear mixed-effects population modelling approach as implemented in NONMEM software.
Time frame: Pre-dose through 60 minutes post-dose
Time to maximum block
Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS.
Time frame: Pre-dose through 60 minutes post-dose
Percentage of maximum block
Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS.
Time frame: Pre-dose through 60 minutes post-dose
Time to patient-ventilator synchrony
Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS.
Time frame: Pre-dose through 60 minutes post-dose
Bispectral index (BIS) - time data
Data will be collected in case-record form and managed by Microsoft Office Excel. Statistical analyses will be performed using SPSS.
Time frame: Pre-dose through 60 minutes post-dose
Plan to share: Undecided
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cisatracurium
Respiratory Distress Syndrome →