NCT02903407

Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU

Pain, Agitation and Delirium Protocol in Ventilated Patients in the Duke CICU

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial step toward understanding the best management of sedation in these patients.

Detailed description

The optimal approach to management of sedation in the Intensive Care Unit (ICU) has become a topic of increasing interest. The most recent guidelines outline the pharmacologic mechanisms of commonly used medications as well as scales on which to measure goals of pain, sedation, agitation and delirium in the critically ill patient. This guideline is based on a cadre of randomized controlled trials examining the medications in the medical intensive care unit and post cardiac surgery patient. Notably, in each of the trials, patients presenting with acute myocardial infarction, heart failure or cardiogenic shock have been excluded or largely underrepresented. Using the current guidelines as a foundation, a new pain, agitation and delirium (PAD) protocol, which prioritizes the use of propofol or dexmedetomidine for sedation, was developed and instituted at Duke University Hospital. However, use of this protocol in the CICU has raised important considerations. Some of these stem from the specific hemodynamic characteristics of the population, including significant bradycardia and hypotension, which can be worsened due to known side effects of propofol and dexmedetomidine. It remains unclear whether the benefits of these medications outweigh the risks in CICU patients as the use of these medications has not been studied previously in this population. This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per CICU usual care, as an initial step toward understanding the best management of sedation in these patients. Project Aims Include: 1. Examine the efficacy of the PAD protocol using propofol or dexmedetomidine versus midazolam with regard to goal sedation, pain control and level of delirium in intubated Duke CICU patients. 2. Determine differences in duration of ventilator days, CICU stay and total hospital stay with the PAD protocol using propofol or dexmedetomidine compared to midazolam in the Duke CICU. 3. Compare the rates of adverse effects of the current PAD protocol with propofol or dexmedetomidine versus midazolam for sedation in the Duke CICU, including hypotension, bradycardia, difficulty with ventilator weaning due to sedation, and delirium.

Conditions

• Deep Sedation
• Ventilators, Mechanical
• Critical Illness

Interventions

Type	Name	Description
DRUG	Midazolam	IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
DRUG	Propofol	IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
DRUG	Dexmedetomidine	IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2016-09-16
• Last updated: 2020-07-13
• Results posted: 2020-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study