Ketamine Infusion as Sedative Analgesic in Severe ARDS (KISS)
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ClinicalTrials.gov Identifier: NCT04818827 |
Recruitment Status :
Completed
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
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Tracking Information | |||||||||||||||
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First Submitted Date | March 19, 2021 | ||||||||||||||
First Posted Date | March 26, 2021 | ||||||||||||||
Last Update Posted Date | March 26, 2021 | ||||||||||||||
Actual Study Start Date | February 1, 2020 | ||||||||||||||
Actual Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures |
All-Cause mortality [ Time Frame: 10 months (throughout the study period) ] The two groups were compared for all-cause mortality during the ICU stay
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Original Primary Outcome Measures | Same as current | ||||||||||||||
Change History | No Changes Posted | ||||||||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title | Ketamine Infusion as Sedative Analgesic in Severe ARDS | ||||||||||||||
Official Title | Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients | ||||||||||||||
Brief Summary | To evaluate whether ketamine is a safe sedative-analgesic agent to be used in an intensive care unit (ICU) setting as compared to traditionally used agents such as propofol, opioids, and midazolam | ||||||||||||||
Detailed Description | According to the 2018 Clinical Practice Guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the intensive care unit (ICU), nonbenzodiazepine sedatives (such as propofol and dexmedetomidine) are preferable to benzodiazepine sedatives (such as midazolam and lorazepam) in critically ill, mechanically ventilated patients. Moreover, continuous use of benzodiazepine (more than 48 hours) has been associated with a risk of prolonged sedation and delirium. On the other hand, though propofol has a remarkable safety profile, it carries unfavorable side effects such as dose-dependent hypotension, hypertriglyceridemia, pancreatitis, and propofol syndrome (which is a rare but potentially fatal complication, associated with high-dose propofol infusions, and characterized by severe metabolic acidosis and circulatory collapse). During the coronavirus disease 2019 (COVID-19) pandemic, an enormous number of patients required mechanical ventilation, which led to the shortage of traditional sedatives such as propofol, dexmedetomidine, midazolam, and lorazepam in the hospitals. In this challenging time, ketamine was used as an alternative sedative infusion. This study is to evaluate whether ketamine is safer compared to other sedatives in severe COVID related ARDS patients. |
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Study Type | Observational | ||||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||||||||||||
Biospecimen | Not Provided | ||||||||||||||
Sampling Method | Non-Probability Sample | ||||||||||||||
Study Population | This study includes patients who are on mechanical ventilators and classified as moderate to severe ARDS with a PF ratio < 150. | ||||||||||||||
Condition |
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Intervention | Not Provided | ||||||||||||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status | Completed | ||||||||||||||
Actual Enrollment |
124 | ||||||||||||||
Original Actual Enrollment | Same as current | ||||||||||||||
Actual Study Completion Date | February 14, 2021 | ||||||||||||||
Actual Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number | NCT04818827 | ||||||||||||||
Other Study ID Numbers | KISS 1.0 | ||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Ramakanth Pata, Interfaith Medical Center | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor | Interfaith Medical Center | ||||||||||||||
Original Study Sponsor | Same as current | ||||||||||||||
Collaborators | Not Provided | ||||||||||||||
Investigators |
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PRS Account | Interfaith Medical Center | ||||||||||||||
Verification Date | March 2021 |