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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01169571
First received: July 21, 2010
Last updated: March 20, 2012
Last verified: March 2012
  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
Intensive Care Unit

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:
  • Clinically significant hypotension (systolic blood pressure <80 mm Hg, diastolic blood pressure <50 mm Hg). [ Time Frame: First 2 hours of study drug administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The incidence of a CMHA. [ Time Frame: 2 - 24 hours ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AEs) between the 3 loading-dose paradigms [ Time Frame: Post-DEX 24-hour observation period ] [ Designated as safety issue: Yes ]
  • Incidence of paradoxical hypertension [ Time Frame: First 2 hours of the post-DEX observation period ] [ Designated as safety issue: Yes ]
  • Incidence of paradoxical hypertension [ Time Frame: 24-hour post-DEX 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: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group I - No loading dose
Group II - Loading dose over 10 minutes
Group III Loading dose over 20 minutes

  Eligibility

Ages Eligible for Study:   18 Years and older
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 ASA classification of 1, 2, 3 or 4.
  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 DEX.
  4. Hypotension based on repeat assessments prior to starting study drug defined as SBP <90 mm Hg or DBP <60 mm Hg.
  5. Pre-existing bradycardia prior 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 DEX 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 Center
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, Canada, TcG 2B7
Red Deer Regional Hlspital Center
Red Deer, Alberta, Canada, T4N 4E7
Canada, British Columbia
Vancouver Coastal Health Authority
Vancouver, British Columbia, Canada, V5Z 3P1
St. Paul's Hospiral
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
St. Mary's General Hospital
Kitchener, Ontario, Canada, N2M 1B2
Intermountain Infusion Services and Research Consultants
Thunder Bay, Ontario, Canada, P7B &c&
Toronto General Hospiral
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
CHA Laval Hospiral
Laval, Quebec, Canada, G1V 4G5
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Royal Viuctora Hospital
Montreal, Quebec, Canada, HeA 1A1
McGill University Health Centre
Montreal, Quebec, Canada, HcG 1A4
CHU Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

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: March 20, 2012
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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 August 01, 2014