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

NCT02903407 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-07-13

Study results available
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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.

Conditions

  • Deep Sedation
  • Ventilators, Mechanical
  • Critical Illness

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kristin Newby, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903407 on ClinicalTrials.gov