--- title: Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients nct_id: NCT01169571 overall_status: COMPLETED sponsor: Hospira, now a wholly owned subsidiary of Pfizer study_type: OBSERVATIONAL primary_condition: Intensive Care Unit countries: Canada canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01169571.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01169571" ct_last_update_post_date: 2015-07-24 last_seen_at: "2026-05-12T06:34:09.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients **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 **NCT ID:** [NCT01169571](https://clinicaltrials.gov/study/NCT01169571) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 373 - **Lead Sponsor:** Hospira, now a wholly owned subsidiary of Pfizer - **Conditions:** Intensive Care Unit - **Start Date:** 2010-09 - **Completion Date:** 2011-06 - **CT.gov Last Update:** 2015-07-24 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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). ``` ## Arms - **Group I - No loading dose** — No loading dose to be administered during the loading-dose paradigms - **Group II - Loading dose over 10 minutes** — Loading dose dexmedetomidine 1 mcg/kg administered over 10 minutes during the loading-dose paradigms - **Group III - Loading dose over 20 minutes** — Loading dose dexmedetomidine 1 mcg/kg administered over 20 minutes during the loading-dose paradigms ## Interventions - **Dexmedetomidine** (DRUG) ## Primary Outcomes - **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. ## 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)_ ## Locations (17) - Foothills Medical Centre, University of Calgary, Calgary, Alberta, Canada - University of Alberta Hospital, Department of Anesthesiology and Pain Medicine, Edmonton, Alberta, Canada - Red Deer Regional Hospital Centre, Alberta Health Services, Red Deer, Alberta, Canada - Vancouver, British Columbia, Canada - St. Paul's Hospital, Vancouver, British Columbia, 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 - Thunder Bay, Ontario, 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 - 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 - Universite de Sherbrooke, Sherbrooke, Quebec, Canada - Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Canada ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.foothills medical centre, university of calgary|calgary|alberta|canada` — added _(2026-05-12)_ - `locations.university of alberta hospital, department of anesthesiology and pain medicine|edmonton|alberta|canada` — added _(2026-05-12)_ - `locations.red deer regional hospital centre, alberta health services|red deer|alberta|canada` — added _(2026-05-12)_ - `locations.|vancouver|british columbia|canada` — added _(2026-05-12)_ - `locations.st. paul's hospital|vancouver|british columbia|canada` — added _(2026-05-12)_ - `locations.capital health-queen elizabeth ii health sciences center|halifax|nova scotia|canada` — added _(2026-05-12)_ - `locations.kingston general hospital|kingston|ontario|canada` — added _(2026-05-12)_ - `locations.st. mary's general hospital|kitchener|ontario|canada` — added _(2026-05-12)_ - `locations.university hospital|london|ontario|canada` — added _(2026-05-12)_ - `locations.|thunder bay|ontario|canada` — added _(2026-05-12)_ - `locations.department of anesthesia, st. michael's hospital|toronto|ontario|canada` — added _(2026-05-12)_ - `locations.toronto general hospital, university health network, department of anesthesia and pain management|toronto|ontario|canada` — added _(2026-05-12)_ - `locations.mcgill university health centre (muhc) royal victoria hospital (rvh)|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.mcgill university health centre, montreal general hospital (mgh)|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.sir mortimer b. davis jewish general hospital|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.universite de sherbrooke|sherbrooke|quebec|canada` — added _(2026-05-12)_ - `locations.département d'anesthésiologie, institut universitaire de cardiologie et de pneumologie de québec|québec||canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01169571.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01169571* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*