Ketamine Infusions in Clinically Depressed ICU Patients

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

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

Contact us for the latest status

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
.
CLS-20545054

Mayo Clinic Footer