Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

Mechanical Ventilation Clinical Trial

Official title:

The Effect of Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030911
• Other study ID #: N-26-2016
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2017
• Last updated: March 24, 2018
• Start date: January 1, 2017
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Dexmedetomidine
• Mechanical Ventilation
• Midazolam
• Sedation

Intervention

Drug:
• Dexmedetomidine
The drug will be administered for sedation and its effect on basal metabolic rate will be investigated
• Midazolam
The drug will be administered for sedation and its effect on basal metabolic rate will be investigated
• Fentanyl
The drug will be administered in both groups

Device:
• Indirect calorimetry
The device will be used for measurement of basal metabolic rate

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Covelli HD, Black JW, Olsen MS, Beekman JF. Respiratory failure precipitated by high carbohydrate loads. Ann Intern Med. 1981 Nov;95(5):579-81. — View Citation

Fung EB. Estimating energy expenditure in critically ill adults and children. AACN Clin Issues. 2000 Nov;11(4):480-97. Review. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate	number of heart beats per minute	24 hours
Secondary	arterial blood pressure	arterial blood pressure measured in mmHg	24 hours
Secondary	Richmond agitation and sedation scale	range from -5 (unarousable) to +4 (combative)	24 hours
Secondary	Plasma interleukin-1ß level	determined by ELISA using a quantitative sandwich enzyme immunoassay technique	24 hours
Secondary	Tumor necrosis factor-a plasma concentration	Enzyme immunoassay	24 hours
Secondary	partial pressure of oxygen in arterial blood	the partial pressure of oxygen in arterial blood measured in mmHg	24 hours
Secondary	VO2	the oxygen consumption measured in mL/Kg/min	24 hours
Secondary	VCO2	carbon dioxide production measured in mL/Kg/min	24 hours
Secondary	end-tidal co2	the pressure of carbon dioxide in expired air measured in mmHg	24 hours
Secondary	cardiac output	the amount of blood pumped by the heart during one minute	24 hours