Critical IllnessPhase 2/3KeMiMofNCT03407404
Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients.
A Phase 2/3 study testing Ketamine-Midazolam and Morphine -Midazolam in people with Critical Illness, run by Makerere University at 1 site in Uganda.
Trial 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. . Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Ketamine-Midazolam and Morphine -Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUganda
- Study dates
- 22 Oct 2017to 30 Jul 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >12years of age.
- Anticipated need for sedation for >24hours.
Who cannot join
- Hypertensive crisis i.e. sustained SBP >200mmHg/DBP>110mmHg
- Status epilepticus
- Ischemic heart disease and severe LV dysfunction
- Persistent tachyarrythmias
- History of mental illness
- Hypersensitivity to ketamine, morphine or midazolam.
- 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
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Mulago National Referral Hospital ICU
Kampala, Central Region, 256
About this study
Official title: Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.
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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Read the 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.
- Conditions
- Critical Illness
- Being tested
- Ketamine-Midazolam, Morphine -Midazolam
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine-MidazolamCombination product
Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.
Morphine -MidazolamCombination product
Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine-midazolam | Experimental | Continous intravenous sedation with a colorless drug mixture in 50ml syringe containing 900mg ketamine and 36mg midazolam. Receives: Combination Product: Ketamine-Midazolam |
| Morphine-Midazolam | Active comparator | Continous intravenous sedation with a colourless drug mixture in 50ml syringes containing 54mg morphine and 36mg midazolam. Receives: Combination Product: Morphine -Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of mechanical ventilation
in hours from start of mechanical ventialtion
Measured: 14 days
incidence of hypotension
incidence of hypotension requiring vasopressor support.
Measured: 14 days
incidence of delirium
assessed daily with the CAM-ICU score
Measured: 14 days
Secondary outcomes (2)
ICU length of stay
length of stay in the intensive care unit from enrollment.
Measured: 14 days
mortality rate
number of deaths in each study arm
Measured: within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start22 Oct 2017
- Primary completion15 Jun 2019
- Study completion30 Jul 2019
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- THRiVE
- Responsible party
- Sponsor
- Investigators
- Christine Namata, MBChB, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407404
- Sponsor's protocol ID
- 2015/HD07/1275U
- Acronym
- KeMiMof
- Status last verified
- Aug 2019
- First submitted
- 5 Jun 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03407404
- Acronym / sponsor ID
- KeMiMof / 2015/HD07/1275U
- Conditions
- Critical Illness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- THRiVE
- Study start
- 22 Oct 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to either receive ketamine-midazolam or morphine-midazolam for continous sedation at enrollment, then followed up for outcomes.
| Arm | Type | Receives |
|---|---|---|
| Ketamine-midazolam | Experimental | Combination Product: Ketamine-MidazolamContinous intravenous sedation with a colorless drug mixture in 50ml syringe containing 900mg ketamine and 36mg midazolam. |
| Morphine-Midazolam | Active comparator | Combination Product: Morphine -MidazolamContinous intravenous sedation with a colourless drug mixture in 50ml syringes containing 54mg morphine and 36mg midazolam. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age >12years of age.
- Anticipated need for sedation for >24hours.
Key exclusion criteria (7 listed)
- Hypertensive crisis i.e. sustained SBP >200mmHg/DBP>110mmHg
- Status epilepticus
- Ischemic heart disease and severe LV dysfunction
- Persistent tachyarrythmias
- History of mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine-MidazolamContinous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation. | Combination product | Ketamine-midazolam |
| Morphine -MidazolamContinous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation. | Combination product | Morphine-Midazolam |
Primary outcome
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
2 secondary outcomes
ICU length of stay
Time frame: 14 days
mortality rate
Time frame: within 14 days
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Namata, MBChB principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine-Midazolam and Morphine -Midazolam in people with Critical Illness, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of mechanical ventilation (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.