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Completed

NCT Number: NCT01169571

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Centre, University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject or the subject's legally authorized representative has voluntarily signed and dated the informed consent document approved by the Research Ethics Board (REB).
  • 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.
  • 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.
  • 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

  • Subjects <18 years of age.
  • 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.
  • Subjects with a known allergy to dexmedetomidine.
  • Hypotension based on repeat assessments prior to (within 15 minutes) starting study drug defined as Systolic BP <90 mmHg or Diastolic BP <60 mmHg.
  • Pre-existing bradycardia prior (within 15 minutes) to starting study drug defined as HR <50 bpm.
  • 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).

Treatment and study plan

Dexmedetomidine

Drug

Primary outcomes

  1. Incidence of clinically meaningful hemodynamic abnormality (CMHA)

    Time frame: During the first 2 hours of study drug administration

    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 outcomes

  1. Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period.

    Time frame: Maintenance infusion period (2 to 24 hours)

  2. Incidence of adverse events (AEs) between the 3 loading-dose paradigms

    Time frame: Post-dexmedetomidine 24-hour observation period

    Adverse events including agitation/anxiety, cardiac dysrhythmias, rebound phenomenon, and signs of withdrawal

  3. Incidence of paradoxical hypertension

    Time frame: During the first 2 hours of the post-dexmedetomidine observation period

  4. Incidence of paradoxical hypertension

    Time frame: Post-dexmedetomidine 24-hour observation period

  5. Amount of analgesics administered

    Time frame: 2 hours prior, and for the first 2 hours during, study drug administration

  6. Amount of sedatives administered

    Time frame: 2 hours prior, and for the first 2 hours during, study drug administration

Sponsors and collaborators

Lead sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Phase 4, Open-Label Study Evaluating the Hemodynamic Effect of Differing Loading Regimens of Precedex in a Post-Surgical Intensive Care Patient Population

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 26, 2010
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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