Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation

NCT00871624 | Completed Phase 2 Results DMC

• 1 other identifier: TuftsMedicalCenter 8533
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine the efficacy and safety of dexmedetomidine during Non-invasive positive pressure ventilation (NPPV) for patients with acute respiratory failure compared to standard analgesic/sedation practices

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Tolerability of NIV as Assessed by an NIV Tolerance Score

  NIV tolerance (NIV intolerance score =1 out of 4) A score of 1 for a comfortable and relaxed patient tolerating NIV; a score of 2 for mild intolerance with some discomfort and occasionally grabbing at the NIV mask; a score of 3 for moderate intolerance and discomfort with the NIV mask most of the time but more frequent grabbing at the mask, sometimes pulling it off; and a score of 4 for severe NIV intolerance with agitation and the inability to leave the NIV mask in place. The outcome measure description of the time frame is reported as the average of the NIV tolerance scores reported at the various time frames (0min, 30min, 60 min, 3hr, 6hr, 12hr, and then every 12hr after the start of NIV therapy up to 72 hours)

  Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours

Secondary Outcomes (1)

• Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive

  Completed at baseline and every 4 hours after the start of NPPV therapy for the duration of the study

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Subjects received active dexmedetomidine 0.2 -0.7 mcg/kg/hr

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Subjects received placebo saline solution 0.2-0.7 mcg/kg/hr

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.

Also known as: Precedex

Dexmedetomidine

Placebo DRUG

Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.

Also known as: Precedex

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Acute respiratory failure requiring the initiation of NPPV
• Admission to the medical ICU service at Tufts Medical Center or Winchester Hospital

You may not qualify if:

• Patients with delirium (intensive care delirium screening checklist score ≥ 4) or disorientation (not oriented to person or place)
• Receiving NPPV for ≥ 8 hours (includes treatment with NPPV at an outside hospital)
• Intubation and mechanical ventilation in the past month based on hospital admission note
• Age ≥ 85 years
• Inability of the potential subject to give informed consent
• Current treatment with antipsychotic agent based on hospital admission note
• Heart rate ≤ 50 bpm
• Systolic blood pressure ≤ 90 mmHg
• History of heart block without pacemaker use or severe ventricular dysfunction (EF ≤25%) based on hospital admission note
• Acute alcohol withdrawal based on hospital admission note
• History of end stage liver failure (based on presence of ≥ 1 or more of the following: AST/ALT ≥ 2 times ULN, INR ≥ 2, total bilirubin ≥ 1.5
• Irreversible brain disease consistent with severe dementia based on hospital admission note
• Pregnancy (all women of child-bearing age will undergo a pregnancy test prior to study enrollment)
• Treatment with clonidine or dexmedetomidine in the past 30 days based on hospital admission note
• Known allergy or sensitivity to clonidine or dexmedetomidine

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Winchester Hospital

Winchester, Massachusetts, 01890, United States

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Russel Roberts, PharmD
• Organization: Tufts Medical Center

rroberts@tuftsmedicalcenter.org

617-636-4576

Study Officials

• Nicholas S Hill, MD

  Tufts Medical Center / Winchester Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 18, 2017
• Results First Posted: December 7, 2015

Record last verified: 2017-11

Locations

US (2)