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Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients. (KeMiMof)

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ClinicalTrials.gov Identifier: NCT03407404
Recruitment Status : Terminated (Futility)
First Posted : January 23, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
THRiVE
Information provided by (Responsible Party):
Makerere University

Tracking Information
First Submitted Date  ICMJE June 5, 2017
First Posted Date  ICMJE January 23, 2018
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE October 22, 2017
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • duration of mechanical ventilation [ Time Frame: 14 days ]
    in hours from start of mechanical ventialtion
  • incidence of hypotension [ Time Frame: 14 days ]
    incidence of hypotension requiring vasopressor support.
  • incidence of delirium [ Time Frame: 14 days ]
    assessed daily with the CAM-ICU score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • ICU length of stay [ Time Frame: 14 days ]
    length of stay in the intensive care unit from enrollment.
  • mortality rate [ Time Frame: within 14 days ]
    number of deaths in each study arm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients.
Official Title  ICMJE Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.
Brief Summary

A prospective, double-blinded, multicenter randomized control trial. All critically ill patients above 12 years of age requiring continuous sedation for >24hrs in the ICU will be screened and those meeting selection criteria (and consented) will be enrolled into the study.

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Detailed Description

165 participants shall be consecutively randomized into either sedation with ketamine-midazolam or morphine-midazolam group using a block sequence technique; group concealed in brown envelopes. Blinding will be at patient/next of kin level as well as investigator/data collector level.

Enrolled subjects shall be followed up for treatment history, co-morbidities and related data will be collected, results analyzed and study findings will be availed to ICU physicians and Ministry of health to guide treatment considerations and for health care planning.

Data shall be collected using a standardized questionnaire by trained research assistants. It will be double entered into Epidata and exported to STATA version 12.0 for analysis. Continuous variables will be expressed as means and standard deviations, while categorical data will be expressed as frequencies with their respective percentages. Linear regression and logistic regression used to analyse primary outcomes, as well as multivariate analysis to detect associations.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be randomized to either receive ketamine-midazolam or morphine-midazolam for continous sedation at enrollment, then followed up for outcomes.
Masking: Double (Participant, Investigator)
Masking Description:

Drugs will be premixed and coded for ketamine-midazolam or morphine-midazolam. The colorless drug mixture shall be provided to the attending physician to start the infusion at 2ml/hour and to be titrated to the desired level of sedation.

The investigator and participant will be unaware of which group a certain patient is under.

Primary Purpose: Treatment
Condition  ICMJE Critical Illness
Intervention  ICMJE
  • Combination Product: Ketamine-Midazolam
    Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.
  • Combination Product: Morphine -Midazolam
    Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.
Study Arms  ICMJE
  • Experimental: Ketamine-midazolam
    Continous intravenous sedation with a colorless drug mixture in 50ml syringe containing 900mg ketamine and 36mg midazolam.
    Intervention: Combination Product: Ketamine-Midazolam
  • Active Comparator: Morphine-Midazolam
    Continous intravenous sedation with a colourless drug mixture in 50ml syringes containing 54mg morphine and 36mg midazolam.
    Intervention: Combination Product: Morphine -Midazolam
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: August 26, 2019)
124
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2018)
165
Actual Study Completion Date  ICMJE July 30, 2019
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age >12years of age.
  2. Anticipated need for sedation for >24hours.

Exclusion Criteria:

  1. Hypertensive crisis i.e. sustained SBP >200mmHg/DBP>110mmHg
  2. Status epilepticus
  3. Ischemic heart disease and severe LV dysfunction
  4. Persistent tachyarrythmias
  5. History of mental illness
  6. Hypersensitivity to ketamine, morphine or midazolam.
  7. Tetanus -due to the muscle rigidity that may be caused by ketamine. Reasons for exclusions 1 to 4; Ketamine stimulates the sympathetic nervous system causing transient increase in myocardial work and blood pressure and has psychoactive effects
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (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 Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03407404
Other Study ID Numbers  ICMJE 2015/HD07/1275U
Has Data Monitoring Committee Yes
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.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Makerere University
Study Sponsor  ICMJE Makerere University
Collaborators  ICMJE THRiVE
Investigators  ICMJE
Principal Investigator: Christine Namata, MBChB Makerere University
PRS Account Makerere University
Verification Date August 2019

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