Intensive Care UnitNCT01169571
Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients
An observational study of Intensive Care Unit, run by Hospira, now a wholly owned subsidiary of Pfizer at 17 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- Dexmedetomidine
- How many people
- 373 participants
- Where
- 17 sitesCanada
- Study dates
- Sep 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Initially intubated and mechanically ventilated post-surgical adult male and female subjects in an intensive care setting.
Who may be able to join
- 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
Show all 14Show fewer
- 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).
Who cannot join
- 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).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Canada17 sites
Foothills Medical Centre, University of Calgary
Calgary, Alberta, T2N 2T9
University of Alberta Hospital, Department of Anesthesiology and Pain Medicine
Edmonton, Alberta, T6G 2G3
Capital Health-Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, 63H 3A7
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St. Mary's General Hospital
Kitchener, Ontario, N2M 1B2
University Hospital
London, Ontario, N6A5A5
McGill University Health Centre (MUHC) Royal Victoria Hospital (RVH)
Montreal, Quebec, H3A 1A1
McGill University Health Centre, Montreal General Hospital (MGH)
Montreal, Quebec, H3G 1A4
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
Red Deer Regional Hospital Centre, Alberta Health Services
Red Deer, Alberta, T4N 4E7
Universite de Sherbrooke
Sherbrooke, Quebec, J1H SN4
Study site
Thunder Bay, Ontario, P7B 7C7
Department of Anesthesia, St. Michael's Hospital
Toronto, Ontario, M56 1W8
Toronto General Hospital, University Health Network, Department of Anesthesia and Pain Management
Toronto, Ontario, M5G 2C4
Study site
Vancouver, British Columbia, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
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
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
- Being tested
- Dexmedetomidine
- Keywords
- Initially intubated, Mechanically ventilated, Post-surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Group I - No loading dose | No loading dose to be administered during the loading-dose paradigms Receives: Drug: Dexmedetomidine | |
| Group II - Loading dose over 10 minutes | Loading dose dexmedetomidine 1 mcg/kg administered over 10 minutes during the loading-dose paradigms Receives: Drug: Dexmedetomidine | |
| Group III - Loading dose over 20 minutes | Loading dose dexmedetomidine 1 mcg/kg administered over 20 minutes during the loading-dose paradigms Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the first 2 hours of study drug administration
Secondary outcomes (6)
Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period.
Measured: Maintenance infusion period (2 to 24 hours)
Incidence of adverse events (AEs) between the 3 loading-dose paradigms
Adverse events including agitation/anxiety, cardiac dysrhythmias, rebound phenomenon, and signs of withdrawal
Measured: Post-dexmedetomidine 24-hour observation period
Incidence of paradoxical hypertension
Measured: During the first 2 hours of the post-dexmedetomidine observation period
Incidence of paradoxical hypertension
Measured: Post-dexmedetomidine 24-hour observation period
Amount of analgesics administered
Measured: 2 hours prior, and for the first 2 hours during, study drug administration
Amount of sedatives administered
Measured: 2 hours prior, and for the first 2 hours during, study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169571
- Sponsor's protocol ID
- DEX-10-03
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2010
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01169571
- Acronym / sponsor ID
- DEX-10-03
- Conditions
- Intensive Care Unit
- Keywords
- Initially intubated, Mechanically ventilated, Post-surgical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I - No loading dose | – | Drug: DexmedetomidineNo loading dose to be administered during the loading-dose paradigms |
| Group II - Loading dose over 10 minutes | – | Drug: DexmedetomidineLoading dose dexmedetomidine 1 mcg/kg administered over 10 minutes during the loading-dose paradigms |
| Group III - Loading dose over 20 minutes | – | Drug: DexmedetomidineLoading dose dexmedetomidine 1 mcg/kg administered over 20 minutes during the loading-dose paradigms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Initially intubated and mechanically ventilated post-surgical adult male and female subjects in an intensive care setting.
Key inclusion criteria (14 listed)
- 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
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine | Drug | Group I - No loading dose, Group II - Loading dose over 10 minutes, Group III - Loading dose over 20 minutes |
Primary outcome
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.
6 secondary outcomes
Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period.
Time frame: Maintenance infusion period (2 to 24 hours)
Incidence of adverse events (AEs) between the 3 loading-dose paradigms
Time frame: Post-dexmedetomidine 24-hour observation period
Incidence of paradoxical hypertension
Time frame: During the first 2 hours of the post-dexmedetomidine observation period
Incidence of paradoxical hypertension
Time frame: Post-dexmedetomidine 24-hour observation period
Amount of analgesics administered
Time frame: 2 hours prior, and for the first 2 hours during, study drug administration
Amount of sedatives administered
Time frame: 2 hours prior, and for the first 2 hours during, study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit, run by Hospira, now a wholly owned subsidiary of Pfizer at 17 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically meaningful hemodynamic abnormality (CMHA) (time frame: During the first 2 hours of study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.