Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01169571
First received: July 21, 2010
Last updated: July 23, 2015
Last verified: July 2015
  Purpose
The objective of this study is to characterize the hemodynamic effects of Precedex (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated post-surgical subjects in an intensive care setting.

Condition Intervention
Intensive Care Unit
Drug: Dexmedetomidine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Phase 4, Open-Label Study Evaluating the Hemodynamic Effect of Differing Loading Regimens of Precedex in a Post-Surgical Intensive Care Patient Population

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Incidence of clinically meaningful hemodynamic abnormality (CMHA) [ Time Frame: During the first 2 hours of study drug administration ] [ Designated as safety issue: Yes ]

    Clinically meaningful hemodynamic abnormalities (CMHA) consist of (any):

    • Heart Rate (HR): A native HR <40 bpm (beats per minute); HR <50 bpm requiring pharmacological intervention; systolic BP <80 mm Hg; if pacing wires are in situ, use of a pacemaker after the start of study drug.
    • Vasoactive Agent Use (i.e. vasopressor or inotrope): the need to add an additional agent to maintain BP; doubling of the dose of any vasoactive agent that was infusing at the start of the study drug.
    • Paradoxical hypertension: the need to add an additional vasodilating agent for control of hypertension; doubling of the dose of any vasodilating agent that was infusing at the start of the study drug.


Secondary Outcome Measures:
  • Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period. [ Time Frame: Maintenance infusion period (2 to 24 hours) ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AEs) between the 3 loading-dose paradigms [ Time Frame: Post-dexmedetomidine 24-hour observation period ] [ Designated as safety issue: Yes ]
    Adverse events including agitation/anxiety, cardiac dysrhythmias, rebound phenomenon, and signs of withdrawal

  • Incidence of paradoxical hypertension [ Time Frame: During the first 2 hours of the post-dexmedetomidine observation period ] [ Designated as safety issue: Yes ]
  • Incidence of paradoxical hypertension [ Time Frame: Post-dexmedetomidine 24-hour observation period ] [ Designated as safety issue: Yes ]
  • Amount of analgesics administered [ Time Frame: 2 hours prior, and for the first 2 hours during, study drug administration ] [ Designated as safety issue: Yes ]
  • Amount of sedatives administered [ Time Frame: 2 hours prior, and for the first 2 hours during, study drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 373
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group I - No loading dose
No loading dose to be administered during the loading-dose paradigms
Drug: Dexmedetomidine
Group II - Loading dose over 10 minutes
Loading dose dexmedetomidine 1 mcg/kg administered over 10 minutes during the loading-dose paradigms
Drug: Dexmedetomidine
Group III - Loading dose over 20 minutes
Loading dose dexmedetomidine 1 mcg/kg administered over 20 minutes during the loading-dose paradigms
Drug: Dexmedetomidine

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Initially intubated and mechanically ventilated post-surgical adult male and female subjects in an intensive care setting.
Criteria

Inclusion Criteria:

  1. Subject or the subject's legally authorized representative has voluntarily signed and dated the informed consent document approved by the Research Ethics Board (REB).
  2. Initially intubated and mechanically ventilated adult post-operative subjects in an intensive care setting (e.g., post operative care unit, post anesthesia care unit, etc.) that are expected to require sedation for at least 2 hours.
  3. Has an American Society of Anesthesiologist (ASA) classification of 1, 2, 3 or 4.

    ASA Physical Status Classification System

    • P1 A normal healthy subject
    • P2 A subject with mild systemic disease
    • P3 A subject with severe systemic disease
    • P4 A subject with severe systemic disease that is a constant threat to life
    • P5 A moribund subject who is not expected to survive without the operation
    • P6 A declared brain-dead subject whose organs are being removed for donor purposes.
  4. If female, subject must be postmenopausal, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:

    • hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
    • intrauterine device (IUD)
    • double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).

Exclusion Criteria:

  1. Subjects <18 years of age.
  2. Subjects with a 2nd degree Mobitz Type II or 3rd degree heart block, unless the subject has a permanent pacemaker or pacing wires are in situ.
  3. Subjects with a known allergy to dexmedetomidine.
  4. Hypotension based on repeat assessments prior to (within 15 minutes) starting study drug defined as Systolic BP <90 mmHg or Diastolic BP <60 mmHg.
  5. Pre-existing bradycardia prior (within 15 minutes) to starting study drug defined as HR <50 bpm.
  6. Subjects who, in the opinion of the Investigator, have any other condition where the risks of dexmedetomidine would be expected to outweigh its benefits (e.g., cardiogenic shock on >2 vasopressors, death anticipated within 48 hours).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169571

Locations
Canada, Alberta
Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital, Department of Anesthesiology and Pain Medicine
Edmonton, Alberta, Canada, T6G 2G3
Red Deer Regional Hospital Centre, Alberta Health Services
Red Deer, Alberta, Canada, T4N 4E7
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
Capital Health-Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, 63H 3A7
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
St. Mary's General Hospital
Kitchener, Ontario, Canada, N2M 1B2
University Hospital
London, Ontario, Canada, N6A5A5
Thunder Bay, Ontario, Canada, P7B 7C7
Toronto General Hospital, University Health Network, Department of Anesthesia and Pain Management
Toronto, Ontario, Canada, M5G 2C4
Department of Anesthesia, St. Michael's Hospital
Toronto, Ontario, Canada, M56 1W8
Canada, Quebec
McGill University Health Centre (MUHC) Royal Victoria Hospital (RVH)
Montreal, Quebec, Canada, H3A 1A1
McGill University Health Centre, Montreal General Hospital (MGH)
Montreal, Quebec, Canada, H3G 1A4
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Universite de Sherbrooke
Sherbrooke, Quebec, Canada, J1H SN4
Canada
Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Hospira, Inc.
  More Information

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01169571     History of Changes
Other Study ID Numbers: DEX-10-03 
Study First Received: July 21, 2010
Last Updated: July 23, 2015
Health Authority: Canada: Health Canada

Keywords provided by Hospira, Inc.:
Initially intubated
Mechanically ventilated
Post-surgical

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016