Ketamine Infusions in Clinically Depressed ICU Patients

Overview

Información sobre este estudio

The long-term goal of this research is to provide a basis for further study of intravenous ketamine infusions compared to placebo intravenous saline infusions to improve depressive symptoms in depressed patients in the Intensive Care Unit.  First, it is important to provide preliminary evidence of the potential improvement in depressive symptoms with intravenous ketamine infusions compared to placebo intravenous saline infusions and to learn about unanticipated challenged of conducting a double-blinded randomized trial.

The objective of this randomized double-blind clinical trial is to obtain initial evidence of the potential benefit of intravenous ketamine infusion compared to placebo intravenous saline infusion for the treatment of depressive symptoms among patients in the ICU and use those estimates to design a larger, multi-center, randomized trial. 

All patients will be receiving standard psychiatric care for any underlying psychiatric condition and standard psychiatric follow‐up by their non-study psychiatrist, who will be making any changes in the treatment deemed warranted by the patient’s condition.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age 18 years to 99 years.
  • Male or female sex.
  • Has been in the Mayo Clinic Florida ICU for the past 1 week.
  • PHQ-9 score of 10 or higher.
  • One of the following diagnoses:
    • acute myocardial infarction;
    • acute renal failure;
    • chronic obstructive pulmonary disease (COPD);
    • congestive heart failure;
    • end-stage liver disease;
    • patients requiring intra-aortic balloon pump (IABP) therapy or continuous renal replacement therapy (CRRT);
    • post-bone marrow transplant;
    • Acute Hypoxemic Respiratory Failure.
    • Acute on Chronic Hypoxemic Respiratory Failure;
    • Pre- or post- Lung, Liver or Heart Transplant or surgical overflows (such as abdominal aortic aneurysm, thoracotomy or tracheostomy).

Exclusion Criteria:

  • Poor vital sign stability hypoxia: O2 < 95%, hypotension: SBP <  90 hypertension: SBP > 180.
  • Heart rate: < 50 or > 120, or Respiratory Rate: < 10 or > 30.
  • Altered mental status.
  • Patient is unwilling to participate or provide informed consent.
  • Any allergy to ketamine or diphenhydramine.
  • Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis.
  • Pregnant or breastfeeding.
  • Presence of intracranial mass or vascular lesion.
  • Presence of a history of psychosis or hallucinations (as assessed by electronic chart review).
  • Weight greater than 115 kg or less than 45kg.
  • History of increased intracranial pressure/hypertensive hydrocephalus or increased intraocular pressure.
  • Patient is acutely psychotic.
  • Provider feels that patient currently or likely will require chemical and/or physical restraints.
  • History of prolonged QT-interval.
  • Current treatment includes any medication known to affect the N‐methyl‐D‐aspartate receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium).
  • Patient in withdrawal from substance abuse or who have used hallucinogens (including cannabis) in the last month for any indication, as determined by the clinical interview and urine drug screening.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Devang Sanghavi, M.B.B.S., M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publicaciones

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CLS-20545054

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