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The Effects of Low Dose Ketamine on Cardiovascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429685
Recruitment Status : Terminated (The focus of the laboratory went a different direction given extramural funding)
First Posted : June 12, 2020
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Craig Crandall, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE June 4, 2020
First Posted Date  ICMJE June 12, 2020
Last Update Posted Date June 15, 2022
Actual Study Start Date  ICMJE November 1, 2020
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
Muscle Sympathetic Nerve Activity Burst Frequency [ Time Frame: This outcome will be assessed within one trial lasting up to approximately five hours ]
We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
Arterial Blood Pressure [ Time Frame: This outcome will be assessed within one trial lasting up to approximately five hours ]
We will measure arterial blood pressure, quantified as systolic, mean, and/or diastolic pressure, using an automated monitor before and after administration of low dose ketamine.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 11, 2020)
Blood Vessel Diameter [ Time Frame: This outcome will be assessed within one trial lasting up to approximately five hours ]
We will measure blood vessel function, quantified as blood vessel diameter, using sonography before and after administration of low dose ketamine.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of Low Dose Ketamine on Cardiovascular Function
Official Title  ICMJE The Effects of Low Dose Ketamine on Cardiovascular Function
Brief Summary Low dose ketamine is used for pain management and for the treatment of anxiety and depression. Prior studies on low dose ketamine have noted short-term (minutes to hours) increases or decreases in blood pressure. Blood pressure that is too high or too low can be problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure. In fact, no prior studies have measured sympathetic nervous system activity after low dose ketamine has been given to an adult. Because sympathetic nervous system activity has a large influence on blood pressure, we need to know how exactly low dose ketamine affects these body systems. Therefore, in this research we will study how low dose ketamine affects sympathetic nervous system activity and cardiovascular function. The results from this research will inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and blood vessels.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
We plan to implement a crossover design. A parallel design is an alternative approach we may consider as the primary outcome is the effect of low dose ketamine on muscle sympathetic nervous system, for which a placebo administration may not be fully necessary.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Ketamine
    Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline
  • Drug: Saline (placebo)
    Saline (placebo)
Study Arms  ICMJE
  • Experimental: Low Dose Ketamine
    Intervention: Drug: Ketamine
  • Placebo Comparator: Saline (placebo)
    Intervention: Drug: Saline (placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 10, 2022)
6
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2020)
40
Actual Study Completion Date  ICMJE May 28, 2021
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-obese (body mass index less than 30 kg/m2)

    *alternatively, individuals will be permitted to participate if they have a body mass index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102 cm for males

  • Systolic blood pressure <140 mmHg
  • Diastolic blood pressure <90 mmHg

Exclusion Criteria:

  • Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
  • Current or previous use of anti-hypertensive medications
  • Any known history of renal or hepatic insufficiency/disease
  • Pregnancy or breast feeding
  • Current smokers, as well as individuals who regularly smoked within the past 3 years
  • Individuals with a history of drug abuse
  • Individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results, but when the agent is abstained for hours/days/weeks, the repeated drug screen is negative. One example could be an over-the-counter supplement)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04429685
Other Study ID Numbers  ICMJE STU-2019-1792
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Craig Crandall, University of Texas Southwestern Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP