Intensive Care Unit SyndromeKISSNCT04818827
Ketamine Infusion as Sedative Analgesic in Severe ARDS
An observational study of Intensive Care Unit Syndrome and Mechanical Ventilation Complication, run by Interfaith Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intensive Care Unit Syndrome, Mechanical Ventilation Complication, Sedatives and Hypnotics Causing Adverse Effects in Therapeutic Use
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 14 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes patients who are on mechanical ventilators and classified as moderate to severe ARDS with a PF ratio < 150.
Who may be able to join
- moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 with an arterial partial pressure of oxygen divided by the inspired oxygen concentration (P/F) ratio < 150 with a minimum 5 cm of positive end-expiratory pressure on a mechanical ventilator
Who cannot join
- post-cardiac arrest status,
- premorbid diagnosis of dementia,
- dependency on extra-corporeal therapies prior to or during ICU stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients
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
Read the 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.
- Conditions
- Intensive Care Unit Syndrome, Mechanical Ventilation Complication, Sedatives and Hypnotics Causing Adverse Effects in Therapeutic Use, Delirium
- Keywords
- ketamine, Mechanical ventilation, sedative analgesic, hospital length of stay, Number of ventilator days, mortality
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | This cohort includes patients who received ketamine as a sedative analgesic agent during mechanical ventilation | |
| Non Ketamine group | This cohort includes patients who received sedatives other than ketamine during mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause mortality
The two groups were compared for all-cause mortality during the ICU stay
Measured: 10 months (throughout the study period)
Secondary outcomes (6)
Hospital length of stay
The two groups were compared for hospital length of stay
Measured: 10 months (throughout the study period)
Duration of ventilator days
The patients in two groups were compared for the duration of ventilator days
Measured: 10 months (throughout the study period)
Infectious complications
The patients in both groups were cultured as clinically suspected for infection. This included blood culture, urine culture and BAL/TTA
Measured: 10 months (throughout the study period)
Acute Kidney Injury
Routine blood samples were obtained that included serum creatinine. Acute kidney injury is defined as per KDIGO
Measured: 10 months (throughout the study period)
Hemodynamic instability
The patients were classified as hemodynamic instability if received vasopressors or ionotropes
Measured: 10 months (throughout the study period)
Delirium after extubation
All patients in the study were routinely screened for delirium using the CAM-ICU score
Measured: 10 months (throughout the study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Feb 2020
- Primary completion30 Nov 2020
- Study completion14 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interfaith Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramakanth Pata, Interfaith Medical Center
- Investigators
- RAMAKANTH PATA, MD, Principal investigator, Interfaith Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818827
- Sponsor's protocol ID
- KISS 1.0
- Acronym
- KISS
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Willing to share all aspects of de-identified data
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT04818827
- Acronym / sponsor ID
- KISS / KISS 1.0
- Conditions
- Intensive Care Unit Syndrome, Mechanical Ventilation Complication, Sedatives and Hypnotics Causing Adverse Effects in Therapeutic Use, Delirium
- Keywords
- ketamine, Mechanical ventilation, sedative analgesic, hospital length of stay, Number of ventilator days, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Interfaith Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 14 Feb 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | – | –This cohort includes patients who received ketamine as a sedative analgesic agent during mechanical ventilation |
| Non Ketamine group | – | –This cohort includes patients who received sedatives other than ketamine during mechanical ventilation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes patients who are on mechanical ventilators and classified as moderate to severe ARDS with a PF ratio < 150.
Key inclusion criteria (1 listed)
- moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 with an arterial partial pressure of oxygen divided by the inspired oxygen concentration (P/F) ratio < 150 with a minimum 5 cm of positive end-expiratory pressure on a mechanical ventilator
Key exclusion criteria (3 listed)
- post-cardiac arrest status,
- premorbid diagnosis of dementia,
- dependency on extra-corporeal therapies prior to or during ICU stay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-Cause mortality
Time frame: 10 months (throughout the study period)
The two groups were compared for all-cause mortality during the ICU stay
6 secondary outcomes
Hospital length of stay
Time frame: 10 months (throughout the study period)
Duration of ventilator days
Time frame: 10 months (throughout the study period)
Infectious complications
Time frame: 10 months (throughout the study period)
Acute Kidney Injury
Time frame: 10 months (throughout the study period)
Hemodynamic instability
Time frame: 10 months (throughout the study period)
Delirium after extubation
Time frame: 10 months (throughout the study period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: Yes. Willing to share all aspects of de-identified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAMAKANTH PATA, MD principal investigator
Interfaith Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome and Mechanical Ventilation Complication, run by Interfaith Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause mortality (time frame: 10 months (throughout the study period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.