Immunomodulatory Properties of Ketamine in Sepsis

NCT01089361 | Completed Phase 1 Results

• 1 other identifier: 2009P000259
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

systemic inflammatory syndrome; sepsis syndrome; septic shock; Cytokine; Ketamine

Outcome Measures

Primary Outcomes (1)

• Serum Levels of IL-6, IL-10 and TNFα

  first 7 days of admission, Baseline and Day 7 reported

Secondary Outcomes (5)

• Adverse Effects Attributable to Ketamine

  7 days

• Organ Failures

  7 days

• Acute Physiology and Chronic Health Evaluation (APACHE) Scores

  First 24 hours after ICU admission

• Length of Intensive Care Unit (ICU) Stay

  28 days

• 28 Day Mortality

  28 days

Other Outcomes (1)

• PCR Substudy

  Daily up to 7 days

Study Arms (2)

Normal saline placebo

PLACEBO COMPARATOR

The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.

Drug: Normal Saline placebo

Ketamine

EXPERIMENTAL

The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.

Drug: Ketamine

Interventions

Ketamine DRUG

The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.

Also known as: Ketamine Hydrochloride, Ketalar

Ketamine

Normal Saline placebo DRUG

The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.

Also known as: 0.9% Sodium Chloride Solution

Normal saline placebo

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 36ºC or \> 38ºC.
• Heart rate of 90 or greater not explained by another medical condition.
• A respiratory rate of \> 20 min-1, a PaCO2 \< 32min-1 or the need for mechanical ventilation.
• A white blood cell count of \< 4000 cell/ml or \> 12000 cells/ml or a WBC showing greater then 10% immature neutrophils.

You may not qualify if:

• pregnant
• increased intracranial pressure or closed head injury
• history of psychotic mental disease
• receiving Continuous Veno - Venous Hemofiltration

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• Calandra T, Bochud PY, Heumann D. Cytokines in septic shock. Curr Clin Top Infect Dis. 2002;22:1-23. No abstract available.

  PMID: 12520644 BACKGROUND

• Laudanski K, Miller-Graziano C, Xiao W, Mindrinos MN, Richards DR, De A, Moldawer LL, Maier RV, Bankey P, Baker HV, Brownstein BH, Cobb JP, Calvano SE, Davis RW, Tompkins RG. Cell-specific expression and pathway analyses reveal alterations in trauma-related human T cell and monocyte pathways. Proc Natl Acad Sci U S A. 2006 Oct 17;103(42):15564-9. doi: 10.1073/pnas.0607028103. Epub 2006 Oct 10.

  PMID: 17032758 BACKGROUND

• Kawasaki T, Ogata M, Kawasaki C, Ogata J, Inoue Y, Shigematsu A. Ketamine suppresses proinflammatory cytokine production in human whole blood in vitro. Anesth Analg. 1999 Sep;89(3):665-9. doi: 10.1097/00000539-199909000-00024.

  PMID: 10475301 BACKGROUND

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome; Shock, Septic

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Daniel Talmor
• Organization: Beth Israel Deaconess Medical Center

dtalmor@bidmc.harvard.edu

617-754-2675

Study Officials

• Daniel Talmor, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 18, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: August 21, 2017
• Results First Posted: August 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)