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

NCT01169571 | Completed

• 1 other identifier: DEX-10-03
• Study Type: observational
• Target: 373
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Intensive Care Unit

Keywords

Initially intubated; Mechanically ventilated; Post-surgical

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically meaningful hemodynamic abnormality (CMHA)

  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.

  During the first 2 hours of study drug administration

Secondary Outcomes (6)

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

  Maintenance infusion period (2 to 24 hours)

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

  Post-dexmedetomidine 24-hour observation period

• Incidence of paradoxical hypertension

  During the first 2 hours of the post-dexmedetomidine observation period

• Incidence of paradoxical hypertension

  Post-dexmedetomidine 24-hour observation period

• Amount of analgesics administered

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

Study Arms (3)

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

Interventions

Dexmedetomidine DRUG

Group I - No loading dose; Group II - Loading dose over 10 minutes; Group III - Loading dose over 20 minutes

Eligibility Criteria

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

Study Population

Initially intubated and mechanically ventilated post-surgical adult male and female subjects in an intensive care setting.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (17)

Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital, Department of Anesthesiology and Pain Medicine

Edmonton, Alberta, T6G 2G3, Canada

Location

Red Deer Regional Hospital Centre, Alberta Health Services

Red Deer, Alberta, T4N 4E7, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Capital Health-Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, 63H 3A7, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

St. Mary's General Hospital

Kitchener, Ontario, N2M 1B2, Canada

Location

University Hospital

London, Ontario, N6A5A5, Canada

Location

Unknown Facility

Thunder Bay, Ontario, P7B 7C7, Canada

Location

Department of Anesthesia, St. Michael's Hospital

Toronto, Ontario, M56 1W8, Canada

Location

Toronto General Hospital, University Health Network, Department of Anesthesia and Pain Management

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University Health Centre (MUHC) Royal Victoria Hospital (RVH)

Montreal, Quebec, H3A 1A1, Canada

Location

McGill University Health Centre, Montreal General Hospital (MGH)

Montreal, Quebec, H3G 1A4, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Universite de Sherbrooke

Sherbrooke, Quebec, J1H SN4, Canada

Location

Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 26, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

CA (17)