NCT03431181

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 16, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

February 4, 2018

Last Update Submit

May 14, 2024

Conditions

VasopressorsHypotensionMean Arterial Pressure TargetsUsual Care

Outcome Measures

Primary Outcomes (1)

  • Plasma high-sensitivity cardiac troponin T at day 3 (primary mechanistic outcome)

    Plasma high-sensitivity cardiac troponin T (hsTnT) at day 3 (corrected for baseline levels) (primary mechanistic outcome)

    Day 3

Secondary Outcomes (17)

  • Concentration of biomarkers associated with tissue injury to the brain

    Days 1 (baseline),3 and 7

  • Concentration of biomarker associated with tissue injury to the liver

    Days 1 (baseline),3 and 7

  • Concentration of biomarker associated with tissue injury to the intestine

    Days 1 (baseline),3 and 7

  • Concentration of biomarker associated with tissue injury to the skeletal muscle

    Days 1 (baseline),3 and 7

  • Concentration of biomarker associated with cardiac wall stress

    Days 1 (baseline),3 and 7

  • +12 more secondary outcomes

Study Arms (2)

MAP target 60-65 mmHg

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Patients in the control arm will receive usual care (as per local practices).

Behavioral: Usual care

Interventions

MAP target 60-65 mmHgBEHAVIORAL

Treating teams will adjust vasopressors to a target MAP range of 60 to 65 mmHg, avoiding vasopressor-induced MAP above this range.

MAP target 60-65 mmHg
Usual careBEHAVIORAL

Patients in the control arm will receive usual care (as per local practices).

Usual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, J1H5N4, Canada

Location

Related Publications (1)

  • Masse MH, Battista MC, Wilcox ME, Pinto R, Marinoff N, D'Aragon F, St-Arnaud C, Mayette M, Leclair MA, Quiroz Martinez H, Grondin-Beaudoin B, Poulin Y, Carbonneau E, Seely AJE, Watpool I, Porteous R, Chasse M, Lebrasseur M, Lauzier F, Turgeon AF, Bellemare D, Mehta S, Charbonney E, Belley-Cote E, Botton E, Cohen D, Lamontagne F, Adhikari NKJ; OVATION-65 team members; Canadian Critical Care Trials Group. Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial. BMJ Open. 2020 Nov 14;10(11):e037947. doi: 10.1136/bmjopen-2020-037947.

    PMID: 33191251DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, professor and researcher

Study Record Dates

First Submitted

February 4, 2018

First Posted

February 13, 2018

Study Start

February 16, 2018

Primary Completion

February 21, 2020

Study Completion

December 31, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

CA(1)