ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT04382170 के लिए प्रलाप वर्तमान में वापस लिया गया है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy चरण II रैंडमाइज़्ड डबल-ब्लाइंड
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT04382170 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन प्रलाप से जुड़ा हुआ है और यह एक चरण II हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में वापस लिया गया चल रहा है। इसकी शुरुआत 1 जून 2020 को हुई थी, और इसमें कुल निर्दिष्ट नहीं प्रतिभागियों के नामांकन की योजना है। Jeff C. Huffman, MD इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 जून 2021 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 13 मई 2024 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
The investigator will examine the safety, tolerability, optimal dose, and preliminary efficacy of dexmedetomidine sublingual film in a randomized, double-blind, controlled trial in 40 hospitalized patients with hyperactive delirium (i.e., delirium with agitation) in the Intensive Care Unit (ICU) setting.
Specific Aim #1 (safety and tolerability): To examine the incidence of cardiovascular and other side effects foll...
और दिखाएँविस्तृत विवरण
Study Intervention
Participants will be randomized to receive either 20 mcg or 60 mcg of dexmedetomidine sublingually. Participants will receive repeat dosing every 30 minutes for up to three additional doses, leading to maximum doses of 80 mcg and 240 mcg, respectively. Both investigators and clinicians will be blind to the participant's group, with only the study pharmacist aware of the dose of medication on the f...
और दिखाएँआधिकारिक शीर्षक
Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy
स्वास्थ्य स्थितियां
प्रलापअन्य अध्ययन आईडी
- 2019P002353
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2020-06
अंतिम अद्यतन प्रकाशित
2024-05-13
अध्ययन की समाप्ति तिथि (अनुमानित)
2021-06
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण II
स्थिति
वापस लिया गया
प्रमुख शब्द
agitation
delirium
dexmedetomidine
delirium
dexmedetomidine
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
चौहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
सक्रिय तुलना समूह20 mcg Participants randomized to the 20mcg group will receive 20mcg of dexmedetomidine sublingual film every 30 minutes, if they continue to have agitation and do not meet any cardiovascular stopping criteria. The maximum dosing for this arm is 80mcg. | Dexmedetomidine sublingual film Dexmedetomidine sublingual film for the management of agitation in hospitalized patients with delirium. |
प्रयोगात्मक60 mcg Participants randomized to the 60mcg group will receive 60mcg of dexmedetomidine sublingual film every 30 minutes, if they continue to have agitation and do not meet any cardiovascular stopping criteria. The maximum dosing for this arm is 240mcg. | Dexmedetomidine sublingual film Dexmedetomidine sublingual film for the management of agitation in hospitalized patients with delirium. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Change in Heart Rate | Heart rate will be assessed participant's flowsheet or using the telemetry monitor for the 6 hours following the initial medication administration. | Baseline, Medication Administration (Hour 0), Hour 0.5, Hour 1, Hour 1.5, Hour 2, Hour 2.5, Hour 3, Hour 3.5, Hour 4, Hour 4.5, Hour 5, Hour 5.5, Hour 6 |
Change in Blood Pressure | Blood pressure will be assessed participant's flowsheet or using the telemetry monitor/automated blood pressure cuff for the 6 hours following the initial medication administration. | Baseline, Medication Administration (Hour 0), Hour 0.5, Hour 1, Hour 1.5, Hour 2, Hour 2.5, Hour 3, Hour 3.5, Hour 4, Hour 4.5, Hour 5, Hour 5.5, Hour 6 |
Change in Oxygen Saturation | Oxygen saturation will be assessed participant's Epic flowsheet or using the telemetry monitor/pulse oximter for the 6 hours following the initial medication administration. | Baseline, Medication Administration (Hour 0), Hour 0.5, Hour 1, Hour 1.5, Hour 2, Hour 2.5, Hour 3, Hour 3.5, Hour 4, Hour 4.5, Hour 5, Hour 5.5, Hour 6 |
Change in QTc Interval | An ECG will be performed intermittently over the 6 hour monitoring period, and QTc will be calculated using the Fridericia formula. | Baseline, Hour 1.5, Hour 3, Hour 4.5, Hour 6 |
Self-reported Side Effects | Incidence of side effects reported for dexmedetomidine in post-marketing surveillance | Hour 6 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Change in Agitation | Agitation will be measured by the Richmond Agitation-Sedation Scale (RASS). RASS is a 10-point scale ranging from -5 to +4, with a more positive score indicating increased agitation. | Baseline, Hour 0.5, Hour 1, Hour 1.5, Hour 2, Hour 2.5, Hour 3, Hour 3.5, Hour 4, Hour 4.5, Hour 6 |
Change in Delirium Severity | Delirium severity will be measured by the Delirium Rating Scale-revised-98 (DRS-R-98). The maximum possible score for severity items is 39, while the maximum total score is 46. Higher scores indicate more severe delirium; score of 0 indicates no delirium. | Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6 |
Time to resolution of agitation | Amount of time from the initial dexmedetomidine administration until agitation resolves measured by RASS score \< 1 | Hour 6 |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Adults hospitalized on a medical or surgical intensive care unit at MGH
- Diagnosis of delirium, assessed according to DSM-5 criteria (DSM-5)
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening
- Weight at least 60 kg (132 pounds), at screening
- In the opinion of the study and clinical teams, sufficiently physically healthy to receive dexmedetomidine sublingual film
Per medical record or team report, diagnoses of:
- Dementia
- Significant traumatic brain injury
- History of stroke, with persistent neurologic deficits
Presence of any of the following cardiovascular comorbidities
- Sick sinus syndrome
- A resting heart rate of < 55 beats per minutes or systolic blood pressure (BP) <100 mmHg or >160 mmHg or diastolic BP <70 mmHg or ˃ 95 mmHg at enrollment and prior to dosing.
- Evidence of cardiac ischemia on a 12-lead electrocardiogram (ECG)
- Corrected QT interval of > 450 msec
- Presence of a permanent pacemaker device
Per medical record (notes, current medications, flowsheets):
- Second degree (or greater) Atrioventricular (AV) block without a pacemaker
- Known allergy or adverse reaction to dexmedetomidine
- Current use of dexmedetomidine
Inability to take sublingual dexmedetomidine due to severe agitation, neurological impairment, nil per os (NPO) status, or other cause.
Hepatic impairment (liver function tests > 3 times the upper limit of normal)
Severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min or on dialysis)
Weight < 60 kg
Pregnancy (in women; tested with serum or urine human chorionic gonadotropin \[hCG\])
Non-fluency in English
Prior enrollment in the study, with receipt of study medication, during the current or a previous hospitalization
Jeff C. Huffman, MDबायोएक्ससेल थेरेप्यूटिक्सअध्ययन उत्तरदायी पक्ष
Jeff C. Huffman, MD, प्रायोजक-अन्वेषक, Director of the Cardiac Psychiatry Research Program, Massachusetts General Hospital
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