Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

NCT03030911 | Completed Phase 4

• 1 other identifier: N-26-2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Mechanical Ventilation; Dexmedetomidine; Midazolam; Sedation

Outcome Measures

Primary Outcomes (1)

• Change in Resting energy expenditure after drug administration

  Resting energy expenditure will be measured using indirect calorimetry via metabolic module on General Electric ventilator

  The first baseline measurement will be taken before drug administration. The second measurement will be taken 24 hours after drug infusion.

Secondary Outcomes (10)

• Heart rate

  24 hours

• arterial blood pressure

  24 hours

• Richmond agitation and sedation scale

  24 hours

• Plasma interleukin-1β level

  24 hours

• Tumor necrosis factor-α plasma concentration

  24 hours

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

* 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

Drug: Dexmedetomidine; Drug: Fentanyl; Device: Indirect calorimetry

midazolam group

PLACEBO COMPARATOR

* 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

Drug: Midazolam; Drug: Fentanyl; Device: Indirect calorimetry

Interventions

Dexmedetomidine DRUG

The drug will be administered for sedation and its effect on basal metabolic rate will be investigated

Also known as: Precedex

Dexmedetomidine group

Midazolam DRUG

The drug will be administered for sedation and its effect on basal metabolic rate will be investigated

Also known as: dormicum

midazolam group

Fentanyl DRUG

The drug will be administered in both groups

Dexmedetomidine group; midazolam group

Indirect calorimetry DEVICE

The device will be used for measurement of basal metabolic rate

Also known as: Calorimetry

Dexmedetomidine group; midazolam group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (4)

• Walker RN, Heuberger RA. Predictive equations for energy needs for the critically ill. Respir Care. 2009 Apr;54(4):509-21.

  PMID: 19327188 BACKGROUND

• Rubinson L, Diette GB, Song X, Brower RG, Krishnan JA. Low caloric intake is associated with nosocomial bloodstream infections in patients in the medical intensive care unit. Crit Care Med. 2004 Feb;32(2):350-7. doi: 10.1097/01.CCM.0000089641.06306.68.

  PMID: 14758147 BACKGROUND

• Covelli HD, Black JW, Olsen MS, Beekman JF. Respiratory failure precipitated by high carbohydrate loads. Ann Intern Med. 1981 Nov;95(5):579-81. doi: 10.7326/0003-4819-95-5-579.

  PMID: 6794409 BACKGROUND

• Fung EB. Estimating energy expenditure in critically ill adults and children. AACN Clin Issues. 2000 Nov;11(4):480-97. doi: 10.1097/00044067-200011000-00002.

  PMID: 11288413 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; Fentanyl; Calorimetry, Indirect; Calorimetry

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Mohamed Abdulatif, Professor

  Professor and member of research committee of anesthesia department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and critical care medicine

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2017
• Primary Completion: March 10, 2018
• Study Completion: March 15, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

EG (1)