Phase 2
Completed N=19
Immunomodulatory Properties of Ketamine in Sepsis
Source: ClinicalTrials.gov NCT01089361 ↗Enrolled (actual)
19
Serious AEs
42.1%
Results posted
Aug 2017
Primary outcomePrimary: Serum Levels of IL-6, IL-10 and TNFα — 28; 16; 9.3; 6.3 pg/mL
Summary
The aim of the study is to assess the effect of short-term infusion of ketamine at analgesic dosage on the immune response, morbidity and mortality among patients suffering from septic shock. We hypothesize that ketamine will modulate the cytokine response to sepsis and reduce morbidity and mortality.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Levels of IL-6, IL-10 and TNFα |
28; 16; 9.3; 6.3; 3227.7; 613.8 | — |
| SECONDARY Adverse Effects Attributable to Ketamine |
0; 2 | — |
| SECONDARY Organ Failures |
3; 2 | — |
| SECONDARY Acute Physiology and Chronic Health Evaluation (APACHE) Scores |
25; 23 | — |
| SECONDARY Length of Intensive Care Unit (ICU) Stay |
19; 20 | — |
| SECONDARY 28 Day Mortality |
4; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients meeting the ACCP/ SCCM definition of severe sepsis will be enrolled in the study. These patients should have a known or suspected source of infection.
- Patients within 12 hours of the development of one or more organ dysfunctions
- Patients must exhibit 3 or more of the following signs of clinical inflammation:
- Core temperature 38ºC.
- Heart rate of 90 or greater not explained by another medical condition.
- A respiratory rate of > 20 min-1, a PaCO2 12000 cells/ml or a WBC showing greater then 10% immature neutrophils.
Exclusion Criteria
- pregnant
- increased intracranial pressure or closed head injury
- history of psychotic mental disease
- receiving Continuous Veno - Venous Hemofiltration
Data sourced from ClinicalTrials.gov (NCT01089361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.