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

NCT03407404 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 2015/HD07/1275U
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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. .

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (3)

• duration of mechanical ventilation

  in hours from start of mechanical ventialtion

  14 days

• incidence of hypotension

  incidence of hypotension requiring vasopressor support.

  14 days

• incidence of delirium

  assessed daily with the CAM-ICU score

  14 days

Secondary Outcomes (2)

• ICU length of stay

  14 days

• mortality rate

  within 14 days

Study Arms (2)

Ketamine-midazolam

EXPERIMENTAL

Continous intravenous sedation with a colorless drug mixture in 50ml syringe containing 900mg ketamine and 36mg midazolam.

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.

Combination Product: Morphine -Midazolam

Interventions

Ketamine-Midazolam COMBINATION_PRODUCT

Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.

Ketamine-midazolam

Morphine -Midazolam COMBINATION_PRODUCT

Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.

Morphine-Midazolam

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>12years of age.
• Anticipated need for sedation for \>24hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makerere University: lead
• THRiVE: collaborator

Study Sites (1)

Mulago National Referral Hospital ICU

Kampala, Central Region, 256, Uganda

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine Namata, MBChB

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to either receive ketamine-midazolam or morphine-midazolam for continous sedation at enrollment, then followed up for outcomes.

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: January 23, 2018
• Study Start: October 22, 2017
• Primary Completion: June 15, 2019
• Study Completion: July 30, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)