Risk Prediction of Dexmedetomidine-associated Hemodynamic Instability

NCT03285087 | Suspended Phase 2 DMC

• 1 other identifier: 17200062
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Hypotension and bradycardia have been commonly associated with dexmedetomidine therapy, occurring in 13% to 68% and 1% to 42% of patients, respectively. The variability in reported incidence may be partially attributed to inconsistent definitions and study populations. The significance of this hemodynamic instability is not only highlighted by its high incidence but also the need for corrective interventions. In one study, hemodynamic instability requiring clinical intervention occurred in nearly one third of ICU patients receiving dexmedetomidine. Moreover, patients who experienced dexmedetomidine-associated hypotension had a higher mortality rate than those who did not.

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• Incidence of hemodynamic instability events during dexmedetomidine

  The primary end point will be the occurrence of at least 1 episode of clinically significant hemodynamic instability during dexmedetomidine therapy defined as systolic blood pressure (SBP) \< 80 mm Hg, diastolic blood pressure (DBP) \<50 mm Hg, or heart rate \<50 beats per minute (bpm) To qualify as an event, the hemodynamic variable had to remain below the specified threshold for at least 2 consecutive readings (≥30 minutes of recorded hemodynamic instability). The cumulative incidence of hemodynamic instability events during dexmedetomidine sedation will be plotted and Cox proportional hazards models will be constructed to determine hazard ratios (HRs) and 95% confidence intervals (CIs) for the risk factors of hemodynamic instability during dexmedetomidine therapy.

  24 hours

Study Arms (1)

DEX 0.2 μg/kg/h

EXPERIMENTAL

Patients will receive dexmedetomidine for sedation with initial maintenance dose rate of 0.2 μg/kg/h. The dose will be increased in 0.1 μg/kg/h increments to achieve target Richmond Agitation Sedation Scale (RASS) levels of -2 to zero and with a maximum dose of 1.4 μg/kg/h for 24 hours.

Drug: DEX 0.2 μg/kg/h.

Interventions

DEX 0.2 μg/kg/h. DRUG

DEX 0.2 μg/kg/h. The dose will be increased in 0.1 μg/kg/h increments to achieve target Richmond Agitation Sedation Scale (RASS) levels of -2 to zero and with a maximum dose of 1.4 μg/kg/h for 24 hours.

Also known as: Precedex

DEX 0.2 μg/kg/h

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients (18-65 years old)
• admitted to Intensive care units in Assiut university Hospital
• requiring endotracheal intubation, mechanical ventilation and light to moderate sedation
• of an estimated duration not less than 24h.

You may not qualify if:

• History of coronary care unit admission.
• Severe traumatic brain injury.
• Low baseline arterial blood pressure defined as SBP \<100 mm Hg or mean arterial blood pressure (MAP) \<70 mm Hg in the 60 minutes preceding dexmedetomidine initiation.
• Slow baseline heart rate was \<70 bpm in the 60 minutes preceding dexmedetomidine initiation.
• Spinal cord injury.
• Patients who have a cardiac pacemaker or automatic implantable cardioverter defibrillator.
• Patients who are admitted with a primary diagnosis of substance withdrawal.
• Pregnant females.
• Patients who are incarcerated.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university main hospital, Trauma ICU

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hala S Abdelghaffar, MD

  Professor of anesthesia, faculty of medicine, Assiut university, Egypt

  PRINCIPAL INVESTIGATOR

• Hala S Abdelghaffar, MD

  Professor of anesthesia, faculty of medicine, Assiut university, Assiut, Egypy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Model Details: The primary end point will be the occurrence of at least 1 episode of clinically significant hemodynamic instability during dexmedetomidine therapy defined as systolic blood pressure (SBP) \< 80 mm Hg, diastolic blood pressure (DBP) \<50 mm Hg, or heart rate \<50 beats per minute (bpm) To qualify as an event, the hemodynamic variable had to remain below the specified threshold for at least 2 consecutive readings (≥30 minutes of recorded hemodynamic instability). The cumulative incidence of hemodynamic instability events during dexmedetomidine sedation will be plotted and Cox proportional hazards models will be constructed to determine hazard ratios (HRs) and 95% confidence intervals (CIs) for the risk factors of hemodynamic instability during dexmedetomidine therapy.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 15, 2017
• Study Start: June 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)