CompletedNot Applicable

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

Canada373 participantsStarted 2010-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.
✓. 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:

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).

What they're measuring

Incidence of clinically meaningful hemodynamic abnormality (CMHA)

Timeframe: During the first 2 hours of study drug administration

Trial details

NCT IDNCT01169571

SponsorHospira, now a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-06

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