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Intraoperative Implementation of the Hypotension Probability Indicator (HYPE)

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ClinicalTrials.gov Identifier: NCT03376347
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Reducing intraoperative hypotension using FlotracIQ with HPI software.

Condition or disease Intervention/treatment
Intraoperative Hypotension Device: FlotracIQ with HPI algorithm

Detailed Description:
Intraoperative hypotension occurs often. Even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia. Currently treatment of these hypotensive episodes is not proactive. Edwards Lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. Hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : November 6, 2018
Estimated Study Completion Date : December 6, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Conventional arm
Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered.
Active Comparator: Treatment arm
FlotracIQ with HPI algorithm.
Device: FlotracIQ with HPI algorithm
FlotracIQ with hypotension probability indicator (HPI) algorithm connected to arterial line. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and what. Timing of treatment and choice of treatment is then left to the discretion of the attending physician.


Outcome Measures

Primary Outcome Measures :
  1. TWA hypotension (measured with FlotracIQ) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min


Secondary Outcome Measures :
  1. Incidence of hypotension (measured with FlotracIQ) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Incidence of hypotension, defined as MAP <65mmHg for ≥1min

  2. Time spent in hypotension (measured with FlotracIQ) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min

  3. TWA hypertension (measured with FlotracIQ) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Time weighted average spent in hypertension, defined as MAP >100 mmHg for ≥1min

  4. Percentage of time in hypertension (measured with FlotracIQ) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Percentage of time in hypertension, defined as MAP >100 mmHg for ≥1min

  5. Incidence of hypertension (measured with FlotracIQ) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Incidence of hypertension, defined as MAP >100 mmHg for ≥1min.

  6. Treatment choice (CRF, EPD) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Medication used to prevent/treat hypotension. A study member is present at the OR to make notes

  7. Treatment dose (CRF, EPD) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes

  8. Time to treatment (CRF) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    time to treatment of hypotension, defined as MAP <65mmHg for ≥1min. A study member is present at the OR to make notes

  9. Diagnostic guidance protocol deviations (CRF) [ Time Frame: intraoperative, starting 15 minutes after induction ]
    Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 years or older
  • Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours
  • Planned to receive general anaesthesia
  • Planned to receive an arterial line during surgery
  • Aim for MAP of 65 mmHg during surgery
  • Being able to give written informed consent prior to surgery

Exclusion Criteria:

  • Aim for MAP other than 65 mmHg at discretion treating physician
  • Significant hypotension before surgery defined as a MAP <65
  • Right- or left sided cardiac failure (e.g. LVEF<35%)
  • Known cardiac shunts (significant)
  • Known aortic stenosis (severe)
  • Severe cardiac arrhythmias including atrial fibrillation
  • Requiring dialysis
  • Liver surgery
  • Vascular surgery with clamping of the aorta
  • Perioperative Goal Directed Therapy (PGDT) protocol
Contacts and Locations

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): NCT03376347


Contacts
Contact: D.P. Veelo, MD, PhD +31 6 5479 5881 d.p.veelo@amc.uva.nl

Locations
Netherlands
Academic Medical Center Amsterdam Recruiting
Amsterdam, Netherlands
Contact: D.P. Veelo, MD, PhD         
Sub-Investigator: M. Wijnberge, MD         
Sub-Investigator: B. Geerts, MD, PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: M.W. Hollmann, MD, PhD Academic Medical Center (AMC), Amsterdam
More Information

Responsible Party: D.P.Veelo, Principal Investigator, Medical Doctor, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03376347     History of Changes
Other Study ID Numbers: NL 6211501817
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
intraoperative
hypotension
Hypotension Probability Index
HPI

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases