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Completed

NCT Number: NCT04818827

Ketamine Infusion as Sedative Analgesic in Severe ARDS

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • post-cardiac arrest status,
  • premorbid diagnosis of dementia,
  • dependency on extra-corporeal therapies prior to or during ICU stay

Treatment and study plan

Primary outcomes

  1. All-Cause mortality

    Time frame: 10 months (throughout the study period)

    The two groups were compared for all-cause mortality during the ICU stay

Secondary outcomes

  1. Hospital length of stay

    Time frame: 10 months (throughout the study period)

    The two groups were compared for hospital length of stay

  2. Duration of ventilator days

    Time frame: 10 months (throughout the study period)

    The patients in two groups were compared for the duration of ventilator days

  3. Infectious complications

    Time frame: 10 months (throughout the study period)

    The patients in both groups were cultured as clinically suspected for infection. This included blood culture, urine culture and BAL/TTA

  4. Acute Kidney Injury

    Time frame: 10 months (throughout the study period)

    Routine blood samples were obtained that included serum creatinine. Acute kidney injury is defined as per KDIGO

  5. Hemodynamic instability

    Time frame: 10 months (throughout the study period)

    The patients were classified as hemodynamic instability if received vasopressors or ionotropes

  6. Delirium after extubation

    Time frame: 10 months (throughout the study period)

    All patients in the study were routinely screened for delirium using the CAM-ICU score

Sponsors and collaborators

Lead sponsor

Interfaith Medical Center

Other

Registry information

Official study title

Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients

Acronym: KISS

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 26, 2021
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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