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

NCT02903407 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00074866
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ventilators, Mechanical; Intensive Care Units; Deep Sedation

Outcome Measures

Primary Outcomes (1)

• Intensive Care Unit Length of Stay

  Number of days of admission to the CICU during the index hospitalization

  One month or hospital discharge, whichever time point comes first

Secondary Outcomes (12)

• In Hospital Mortality

  One month or hospital discharge, whichever time point comes first

• Hospital Length of Stay

  One month or hospital discharge, whichever time point comes first

• Number of Participants With Increased Vasopressor Requirement

  One month or hospital discharge, whichever time point comes first

• Number of Participants With Bradycardia

  One month or hospital discharge, whichever time point comes first

• Number of Ventilator Days

  One month or hospital discharge, whichever time point comes first

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.

Drug: Midazolam

Propofol or Dexmedetomidine

ACTIVE COMPARATOR

Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.

Drug: Propofol; Drug: Dexmedetomidine

Interventions

Midazolam DRUG

IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.

Also known as: Versed

Midazolam

Propofol DRUG

IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.

Also known as: Diprivan

Propofol or Dexmedetomidine

Dexmedetomidine DRUG

IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.

Also known as: Precedex

Propofol or Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (8)

• Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.

  PMID: 23269131 BACKGROUND

• Carson SS, Kress JP, Rodgers JE, Vinayak A, Campbell-Bright S, Levitt J, Bourdet S, Ivanova A, Henderson AG, Pohlman A, Chang L, Rich PB, Hall J. A randomized trial of intermittent lorazepam versus propofol with daily interruption in mechanically ventilated patients. Crit Care Med. 2006 May;34(5):1326-32. doi: 10.1097/01.CCM.0000215513.63207.7F.

  PMID: 16540958 BACKGROUND

• Hall RI, Sandham D, Cardinal P, Tweeddale M, Moher D, Wang X, Anis AH; Study Investigators. Propofol vs midazolam for ICU sedation : a Canadian multicenter randomized trial. Chest. 2001 Apr;119(4):1151-9. doi: 10.1378/chest.119.4.1151.

  PMID: 11296183 BACKGROUND

• Huey-Ling L, Chun-Che S, Jen-Jen T, Shau-Ting L, Hsing-I C. Comparison of the effect of protocol-directed sedation with propofol vs. midazolam by nurses in intensive care: efficacy, haemodynamic stability and patient satisfaction. J Clin Nurs. 2008 Jun;17(11):1510-7. doi: 10.1111/j.1365-2702.2007.02128.x.

  PMID: 18482144 BACKGROUND

• Pandharipande PP, Sanders RD, Girard TD, McGrane S, Thompson JL, Shintani AK, Herr DL, Maze M, Ely EW; MENDS investigators. Effect of dexmedetomidine versus lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized controlled trial. Crit Care. 2010;14(2):R38. doi: 10.1186/cc8916. Epub 2010 Mar 16.

  PMID: 20233428 BACKGROUND

• Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.

  PMID: 19188334 BACKGROUND

• Searle NR, Cote S, Taillefer J, Carrier M, Gagnon L, Roy M, Lussier D. Propofol or midazolam for sedation and early extubation following cardiac surgery. Can J Anaesth. 1997 Jun;44(6):629-35. doi: 10.1007/BF03015447.

  PMID: 9187783 BACKGROUND

• Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.

  PMID: 22436955 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Midazolam; Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Our trial was terminated prior to goal enrollment due to difficulty with enrollment in this critically ill population of patients. The data here represent a small sample size of patients and should be viewed as pilot data for hypothesis generation.

Results Point of Contact

• Title: Angela Lowenstern
• Organization: Duke University

angela.sandelin@duke.edu

919-684-0111

Study Officials

• Kristin Newby, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 13, 2020
• Results First Posted: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)