Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

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: NCT03030911
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Tracking Information
First Submitted Date  ICMJE January 19, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date March 27, 2018
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date March 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Change in Resting energy expenditure after drug administration [ Time Frame: The first baseline measurement will be taken before drug administration. The second measurement will be taken 24 hours after drug infusion. ]
Resting energy expenditure will be measured using indirect calorimetry via metabolic module on General Electric ventilator
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2017)
  • Heart rate [ Time Frame: 24 hours ]
    number of heart beats per minute
  • arterial blood pressure [ Time Frame: 24 hours ]
    arterial blood pressure measured in mmHg
  • Richmond agitation and sedation scale [ Time Frame: 24 hours ]
    range from -5 (unarousable) to +4 (combative)
  • Plasma interleukin-1β level [ Time Frame: 24 hours ]
    determined by ELISA using a quantitative sandwich enzyme immunoassay technique
  • Tumor necrosis factor-α plasma concentration [ Time Frame: 24 hours ]
    Enzyme immunoassay
  • partial pressure of oxygen in arterial blood [ Time Frame: 24 hours ]
    the partial pressure of oxygen in arterial blood measured in mmHg
  • VO2 [ Time Frame: 24 hours ]
    the oxygen consumption measured in mL/Kg/min
  • VCO2 [ Time Frame: 24 hours ]
    carbon dioxide production measured in mL/Kg/min
  • end-tidal co2 [ Time Frame: 24 hours ]
    the pressure of carbon dioxide in expired air measured in mmHg
  • cardiac output [ Time Frame: 24 hours ]
    the amount of blood pumped by the heart during one minute
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Heart rate [ Time Frame: 24 hours ]
  • arterial blood pressure [ Time Frame: 24 hours ]
  • Richmond agitation and sedation scale [ Time Frame: 24 hours ]
    range from -5 (unarousable) to +4 (combative)
  • Plasma interleukin-1β level [ Time Frame: 24 hours ]
    determined by ELISA using a quantitative sandwich enzyme immunoassay technique
  • Tumor necrosis factor-α plasma concentration [ Time Frame: 24 hours ]
    Enzyme immunoassay
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients
Official Title  ICMJE The Effect of Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients: Randomized Controlled Study
Brief Summary The aim of this study is to compare the effect of dexmedetomidine on resting energy expenditure in relation to the midazolam in critically ill patients using indirect calorimetry
Detailed Description

Caloric needs in critically-ill patients fluctuate significantly over the course of the disease which might expose patients to either malnutrition or overfeeding. Malnutrition is associated with deterioration of lean body mass, poor wound healing, increased risk of nosocomial infection, and weakened respiratory muscles. On the other hand overfeeding in medically compromised patients can promote lipogenesis, hyperglycemia, and exacerbation of respiratory failure. Many factors may affect the resting energy expenditure (REE) through manipulation of oxygen consumption (VO2).

Sedatives are important contributors to reduction of REE. The postulated mechanism of sedative-induced reduction of VO2 is inhibition of circulating catecholamine and pro-inflammatory cytokines.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist. Stimulation of the α2-adrenoceptor in the central nervous system causes a 60-80% reduction in sympathetic outflow and endogenous catecholamine levels. It was found that perioperative use of α2 agonists decreased sympathetic activity with subsequent reduction of VO2 and REE. Moreover, dexmedetomidine, has some anti-inflammatory effect by inhibiting the pro-inflammatory cytokines which may cause additional reduction of REE in critically ill patient.

Midazolam is another important sedative that is frequently used in critically-ill patient. Terao et al. found that increasing the depth of sedation using midazolam, decreased oxygen consumption and REE. However, it remains unclear whether the effect of midazolam on REE is related to the drug itself or to the depth of sedation.

There is no direct comparison in the literature between dexmedetomidine and midazolam on REE.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mechanical Ventilation
  • Dexmedetomidine
  • Midazolam
  • Sedation
Intervention  ICMJE
  • Drug: Dexmedetomidine
    The drug will be administered for sedation and its effect on basal metabolic rate will be investigated
    Other Name: Precedex
  • Drug: Midazolam
    The drug will be administered for sedation and its effect on basal metabolic rate will be investigated
    Other Name: dormicum
  • Drug: Fentanyl
    The drug will be administered in both groups
  • Device: Indirect calorimetry
    The device will be used for measurement of basal metabolic rate
    Other Name: Calorimetry
Study Arms  ICMJE
  • Active Comparator: Dexmedetomidine group
    • Patients will receive analgesia with fentanyl at a fixed dose of 1 µg.kg.hr-1. Each patient will receive the study drug within 24 hours after intubation. Sedatives used before study enrolment will be discontinued 6 hours prior to the initiation of study drug.
    • Group I patients will have dexmedetomidine (0.075 µg.kg-1.mL-1). Dexmedetomidine infusion will be started at 0.15 µg.kg-1.hr-1 (2 mL.hr-1) and will be adjusted by 0.15 µg.kg-1.h-1 increments to a maximum of 0.75 µg/kg/h (10 ml.h-1)
    • Intervention: indirect calorimetry
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Fentanyl
    • Device: Indirect calorimetry
  • Placebo Comparator: midazolam group
    • Patients will receive analgesia with fentanyl at a fixed dose of 1 µg.kg.hr-1. Each patient will receive the study drug within 24 hours after intubation. Sedatives used before study enrolment will be discontinued 6 hours prior to the initiation of study drug.
    • Group II patients will have midazolam (0.5 mg.mL-1). Midazolam will be started at 1 mg.h-1 (2 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (10 mL.h-1). All infusions will be adjusted by increments of 2 mL.hr-1 to maintain blinding. Patients in either group not adequately sedated by the maximum infusion rate of the study medication will receive a bolus dose of fentanyl 0.5 µg.kg-1.
    • Intervention: indirect calorimetry
    Interventions:
    • Drug: Midazolam
    • Drug: Fentanyl
    • Device: Indirect calorimetry
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: January 23, 2017)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2018
Actual Primary Completion Date March 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The study will be designed to recruit 30 critically-ill patients who will be admitted to the surgical ICU for ventilatory support and will be expected to continue for 2 days or longer.

Exclusion Criteria:

  • Age < 18 years old.
  • Pregnant patient.
  • Serious central nervous system pathologies (traumatic brain injury, acute stroke, uncontrolled seizures).
  • Patient who will require fraction of inspired oxygen more than 0.6.
  • Air leak from the chest tube.
  • Patient with body temperature > 39 Celsius.
  • Acute hepatitis or severe liver disease (Child-Pugh class C).
  • Left ventricular ejection fraction less than 30%.
  • Heart rate less than 50 beats/min.
  • Second or third degree heart block.
  • Systolic pressure < 90 mmHg despite of infusion of 2 vasopressors.
  • Patients with known endocrine dysfunction.
  • Patient with hypothermia
  • Patient on Positive end expiratory pressure more than 14 cmH2o
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03030911
Other Study ID Numbers  ICMJE N-26-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmed Hasanin, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mohamed Abdulatif, Professor Professor and member of research committee of anesthesia department
PRS Account Cairo University
Verification Date March 2018

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