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Ketamine In Thoracic Surgery (KITS) Trial (KITS)

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: NCT00504725
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : November 16, 2012
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE July 18, 2007
First Posted Date  ICMJE July 20, 2007
Results First Submitted Date  ICMJE September 29, 2011
Results First Posted Date  ICMJE November 16, 2012
Last Update Posted Date July 25, 2014
Study Start Date  ICMJE July 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
Interleukin Levels at 24 Hours [ Time Frame: 24 Hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
The primary endpoint for the study is interleukin 6 profile at 0, 4 and 24 hours after surgery. We will use two way ANOVA (looking for effects due to drug and time) with a p value of 0.05 indicative of statistical significance. [ Time Frame: 24 Hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • C-reactive Protein (CRP) Serum Levels [ Time Frame: 24 hours ]
    The CRP levels were measured 24 hours postoperatively.
  • Verbal Pain Scores [ Time Frame: baseline, 4 hours, 24 hours and at discharge ]
    Pain scores rated by the subject on a scale of 0 low - 10 high
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
Secondary endpoints will be compared using chi squared tests for rates and ANOVA for changes in VAS and other serum analytes. Patients will be monitored at each time point for hallucinations and cardiac vascular complications. [ Time Frame: 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine In Thoracic Surgery (KITS) Trial
Official Title  ICMJE Ketamine In Thoracic Surgery (KITS) Trial
Brief Summary The primary aim of the study is to demonstrate a reduction in circulating interleukin 6 levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when patients are given either ketamine or placebo (0.9% saline in equivalent volume). The alternative (two tailed) hypothesis (HA) if the null is disproved is that ketamine leads to significantly different levels of interleukin 6 at 4 and 24 hours after completion of surgery. We plan to randomize 40 patients to receive either ketamine or placebo, in a block of 4 randomization design stratified by whether surgery is performed by VATS or open lobectomy.
Detailed Description

This study is designed to be a phase 2 (efficacy) randomized controlled clinical trial of ketamine versus placebo in 40 patients undergoing lobectomy by VATS or open approach, at Duke University. We selected a single dose regimen of 0.5mg/kg IV ketamine given at induction of anesthesia, as this is the dose that previously has been shown to induce maximal suppression of the IL-6 response in cardiac surgery.

We plan to randomize 40 patients to receive either ketamine or placebo, in a block of 4 randomization design stratified by whether surgery is performed by VATS or open lobectomy. 40 patients (n=20 per group) will provide 90% power to detect a change in IL 6 of 20 pg/ml from a mean of 100 pg/ml at 4 hours, with two tailed alpha = 0.05. Allowing for 10-20% attrition we will enroll 50 patients to achieve this sample size. All patients presenting for lobectomy either VATS or open will be included. Patients will be screened by review of the preoperative surgical schedule posted each day and approached for consent to participate if they do not have any exclusion criteria. Patients who are randomized but do not undergo lobectomy for any reason will not be included in the analysis of the primary endpoint. Patients who are listed for VATS resection but convert to open will be included in the analysis on a per protocol basis. The randomization is stratified according to planned approach (VATS vs open), however we expect the majority of these cases to be VATS lobectomies.

Treatment will be by intravenous administration of a single dose of study drug over 5 minutes immediately after induction of anesthesia and before surgical incision.

Patients will be randomized (by sealed envelope) in blocks of 4 to receive ketamine or placebo. The randomization will be stratified according to whether the planned surgery is via VATS or open (thoracotomy) approach. The study drug will be prepared by the investigational pharmacy and provided to the attending anesthesiologist of record for the case. It will contain 0.5 mg/kg ketamine for injection by IV bolus over 5 minutes, or as an equivalent volume of 0.9% saline. It will be the responsibility of the principal investigator to ensure that study drug is administered in a timely fashion, usually by delegation to the attending anesthesiologist of record for the case. The anesthetic procedure will be standardized in that each patient will receive a total intravenous anesthetic using propofol and an intravenous opioid infusion. This anesthetic will be supplemented by an epidural and intravenous opioid boluses as needed to control pain.

Visits by the research team will be performed as follows:

  1. Visit 1 will occur at enrollment, when baseline information (see CRF visit 1) will be collected and study consent forms signed.
  2. Visit 2 will occur at induction of anesthesia when study drug will be administered and a baseline blood sample of 10ml collected from the patient's arterial line. The blood sample will be immediately centrifuged and the serum frozen and stored for subsequent analysis.
  3. Visit 3 will occur at 4 hours after completion of surgery when 10 ml blood will be collected and CRF visit 3 form will be completed (VAS score and emergence delirium).
  4. Visit 4 will occur at 24 hours after completion of surgery when 10 ml blood will be collected and CRF visit 4 form will be completed (VAS score).
  5. The final visit will occur just prior to hospital discharge when CRF visit 5 form will be completed (secondary endpoints). Additionally, if the principal investigator is informed by either study staff or the clinical team of an adverse event or other complication, then the patient will be visited within 24 hours for confirmation of the event and ascertainment of whether the event is related to study drug or not. An SAE form will be completed and sent to the IRB in line with institutional policy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Ketamine
    Interventional
  • Drug: 0.9% saline
    placebo
Study Arms  ICMJE
  • Experimental: Ketamine
    Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    0.9 % saline bolus of equivalent volume
    Intervention: Drug: 0.9% saline
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2007)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients presenting for lobectomy either VATS or open.

Exclusion Criteria:

  • Patients with myocardial infarction in the previous six months,
  • Patients with a history of psychotic disorder,
  • Patients with a history of chronic pain syndrome,
  • Patients with documented previous allergy to ketamine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
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 NCT00504725
Other Study ID Numbers  ICMJE Pro00000895
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andy Shaw, M. D. Duke University
PRS Account Duke University
Verification Date November 2012

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