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

Stopped early · Phase 4

Conditions studied: Deep Sedation, Ventilators, Mechanical, Critical Illness

In brief

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.

Key facts

Study ID

NCT02903407

Run by

Duke University

People needed

7

Starts

2017-09-01

Expected to finish

2019-06-30

Last updated by the study team

2020-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients admitted to the Duke CICU, who require intubation and sedation for mechanical ventilation that is expected to be >24 hours in duration will be included, unless they meet the specified exclusion criteria.
• Patients intubated within one hour prior to care transition to the CICU will also be screened for inclusion.

You may not qualify if…

• Exclusion criteria include patients following resuscitation from cardiac arrest who are treated on the cooling protocol
• patients who have suffered a neurologic event (seizure, stroke) or who have baseline dementia, both of which could limit delirium assessment
• patients with child class B and C liver disease
• patients with known allergy to study medications.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.