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

Intensive Care Unit Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169571
• Other study ID #: DEX-10-03
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: July 23, 2015
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2015
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Intensive Care Unit

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
Canada	Foothills Medical Centre, University of Calgary	Calgary	Alberta
Canada	University of Alberta Hospital, Department of Anesthesiology and Pain Medicine	Edmonton	Alberta
Canada	Capital Health-Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	St. Mary's General Hospital	Kitchener	Ontario
Canada	University Hospital	London	Ontario
Canada	McGill University Health Centre (MUHC) Royal Victoria Hospital (RVH)	Montreal	Quebec
Canada	McGill University Health Centre, Montreal General Hospital (MGH)	Montreal	Quebec
Canada	Sir Mortimer B. Davis Jewish General Hospital	Montreal	Quebec
Canada	Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec	Quebec
Canada	Red Deer Regional Hospital Centre, Alberta Health Services	Red Deer	Alberta
Canada	Universite de Sherbrooke	Sherbrooke	Quebec
Canada	Department of Anesthesia, St. Michael's Hospital	Toronto	Ontario
Canada	Toronto General Hospital, University Health Network, Department of Anesthesia and Pain Management	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period.		Maintenance infusion period (2 to 24 hours)	Yes
Secondary	Incidence of adverse events (AEs) between the 3 loading-dose paradigms	Adverse events including agitation/anxiety, cardiac dysrhythmias, rebound phenomenon, and signs of withdrawal	Post-dexmedetomidine 24-hour observation period	Yes
Secondary	Incidence of paradoxical hypertension		During the first 2 hours of the post-dexmedetomidine observation period	Yes
Secondary	Incidence of paradoxical hypertension		Post-dexmedetomidine 24-hour observation period	Yes
Secondary	Amount of analgesics administered		2 hours prior, and for the first 2 hours during, study drug administration	Yes
Secondary	Amount of sedatives administered		2 hours prior, and for the first 2 hours during, study drug administration	Yes