Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimal VAsopressor TitraTION in Patients 65 Years and Older (OVATION-65)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431181
Recruitment Status : Active, not recruiting
First Posted : February 13, 2018
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
François Lamontagne, Université de Sherbrooke

Brief Summary:
We have designed OVATION-65 to evaluate the effects of permissive low blood pressure compared to usual care on markers of organ injury and survival in older patients.

Condition or disease Intervention/treatment Phase
Vasopressors Hypotension Mean Arterial Pressure Targets Usual Care Behavioral: MAP target 60-65 mmHg Behavioral: Usual care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Optimal VAsopressor TitraTION in Patients 65 Years and Older (OVATION-65)
Actual Study Start Date : February 16, 2018
Actual Primary Completion Date : February 21, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: MAP target 60-65 mmHg
Treating teams will adjust vasopressors to a target MAP range of 60 to 65 mmHg, avoiding vasopressor-induced MAP above this range.
Behavioral: MAP target 60-65 mmHg
Treating teams will adjust vasopressors to a target MAP range of 60 to 65 mmHg, avoiding vasopressor-induced MAP above this range.

Active Comparator: Usual Care
Patients in the control arm will receive usual care (as per local practices).
Behavioral: Usual care
Patients in the control arm will receive usual care (as per local practices).




Primary Outcome Measures :
  1. Plasma high-sensitivity cardiac troponin T at day 3 (primary mechanistic outcome) [ Time Frame: Day 3 ]
    Plasma high-sensitivity cardiac troponin T (hsTnT) at day 3 (corrected for baseline levels) (primary mechanistic outcome)


Secondary Outcome Measures :
  1. Concentration of biomarkers associated with tissue injury to the brain [ Time Frame: Days 1 (baseline),3 and 7 ]
    Concentration of biomarkers associated with tissue injury to the brain (plasma GFAP, plasma Myelin Basic Protein and serum NSE)

  2. Concentration of biomarker associated with tissue injury to the liver [ Time Frame: Days 1 (baseline),3 and 7 ]
    Concentration of biomarker associated with tissue injury to the liver (plasma ALT)

  3. Concentration of biomarker associated with tissue injury to the intestine [ Time Frame: Days 1 (baseline),3 and 7 ]
    Concentration of biomarker associated with tissue injury to the intestine (plasma fatty acid binding protein (FABP))

  4. Concentration of biomarker associated with tissue injury to the skeletal muscle [ Time Frame: Days 1 (baseline),3 and 7 ]
    Concentration of biomarker associated with tissue injury to the skeletal muscle (plasma creatinine kinase).

  5. Concentration of biomarker associated with cardiac wall stress [ Time Frame: Days 1 (baseline),3 and 7 ]
    Concentration of biomarker associated with cardiac wall stress (plasma N-terminal pro-B-type natriuretic peptide [NT-proBNP]).

  6. Global tissue dysoxia [ Time Frame: Days 1 (baseline),3 and 7 ]
    Global tissue dysoxia will be assessed through plasma lactate

  7. Plasma high-sensitivity cardiac troponin T (hsTnT) [ Time Frame: Day 7 ]
    Plasma high-sensitivity cardiac troponin T (hsTnT) at day 7

  8. Pre-specified adverse events [ Time Frame: 28 days ]
    Pre-specified adverse events assessed by events of stroke, clinically detected supraventricular arrhythmia, acute kidney injury (KDIGO stage 3), limb or intestinal ischemia

  9. Organ function [ Time Frame: Days 1 (baseline), 2, 3, 4, 7, 10, 14 and 28 ]
    Organ function using SOFA score (measured at baseline (day 1) and on days 2,3,4,7,10,14 and 28 while in the ICU)

  10. Mortality [ Time Frame: 90 days and 6 months ]
    Mortality at 90 days and at 6 months will be assessed during the phone call at 6 months

  11. 6-month cognitive impairment [ Time Frame: 6 months ]
    6-month cognitive impairment assessed by Telephone Interview for Cognitive Status (TICS)

  12. Healthcare utilization [ Time Frame: 28 days ]
    Healthcare utilization assessed by measuring duration of mechanical ventilation, renal replacement therapy, vasopressor therapy and ICU and hospital stay (through days of utilization)

  13. Plasma level of ascorbic acid (outcome for ancillary study) [ Time Frame: Day 1 (baseline) ]
    Plasma level of ascorbic acid (measured at baseline (day 1))

  14. Biomarkers of ascorbic acid deficiency-related organ injury (outcome for ancillary study) [ Time Frame: Days 1 (baseline), 3 and 7 ]
    Inflammation (IL-1ß; TNF-α; CRP) and endothelial injury (thrombomodulin, angiopoietin-2)

  15. Discovery proteomic approach to identify peptides and proteins expressed in the urine (outcome for ancillary study) [ Time Frame: Days 1 (baseline), 3 and 7 ]
    Discovery proteomic approach through novel urine biomarkers

  16. Validate the predictive value of five prespecified biomarkers of renal injury in urine using a proteomic approach (outcome for ancillary study): TIMP2, NGAL, FABPL, CYTC, IGFBP7 [ Time Frame: Days 1 (baseline), 3 and 7 ]
    Proteomic discovery approach through validation of prespecified urine biomarkers: TIMP2, NGAL, FABPL, CYTC, IGFBP7

  17. Impact of vasopressor regimen on the immune response, adrenergic receptor activity and related proteomic signature of peripheral blood mononuclear cell (PBMC) (outcome for ancillary study) [ Time Frame: Day 1 (baseline) and 7 ]
    Immune response, adrenergic receptor activity and proteomic profile through Th1/Th2 profiling, PBMC adrenergic receptors AMPc activity and proteomic signature and associations with responses to catecholamines.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 65 years or older
  2. Working diagnosis of vasodilatory hypotension as assessed by treating team
  3. Vasopressors started for 12 hours or less (window from ICU admission after/during adequate fluid resuscitation as assessed by treating physician)
  4. Vasopressors expected for 6 additional hours as assessed by the treating team

Exclusion Criteria:

  1. Actively treated for spinal cord injury or acute brain injury
  2. Vasopressors being given solely for bleeding, acute ventricular failure or post-cardiopulmonary bypass vasoplegia
  3. Lacking commitment to life-sustaining therapies (expected withdrawal of life-sustaining treatments within the next 48 hours
  4. Death perceived as imminent
  5. Previously enrolled in OVATION-65
  6. Organ transplant within the last year
  7. Extra corporeal life support at baseline
  8. The treating physician(s) lacks equipoise regarding the overall effects of permissive hypotension versus usual care on patient important outcomes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431181


Locations
Layout table for location information
Canada, Quebec
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada, J1H5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Layout table for investigator information
Principal Investigator: François Lamontagne, MD FRCPC MSc University of Sherbrooke and CIUSSS de l'Estrie-CHUS
Principal Investigator: Neill Adhikari, MDCM MSc Sunnybrook Health Sciences Centre, University of Toronto
Layout table for additonal information
Responsible Party: François Lamontagne, Doctor, professor and researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03431181    
Other Study ID Numbers: MP-31-2018-1789
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Vascular Diseases
Cardiovascular Diseases