- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05964374
Goal-Directed Therapy Following Cardiac Surgery
Goal-Directed Therapy (GDT) Using Hypotension Prediction Index (HPI) Following Cardiac Surgery: a Pilot Randomized Control Trial
Study Overview
Detailed Description
Rationale:
Goal-directed therapy (GDT) has been shown to reduce complications and length of stay on cardiac surgery patients. Unfortunately, the existing literature on GDT in CV surgery has several limitations, which creates uncertainty over the expected benefit of implementing this care element with high associated costs and impact on workflow. Hypotension Prediction Index (HPI) is a proprietary algorithm that utilizes pulse contour analysis from invasive arterial pressure monitoring to identify patients at risk for becoming hypotensive within 15 minutes. The algorithm was developed using machine learning on a large surgical/ICU data set, and then externally validated on non-cardiac and cardiac surgical patients. HPI, as part of a GDT algorithm, may allow healthcare providers to identify patients recovering from cardiac surgery who may benefit from optimization prior to becoming hypotensive and assist with selecting the most appropriate hemodynamic intervention.
Hypothesis:
Application of an HPI-based GDT algorithm will result in a difference in cumulative fluid administration over the first 24-hours of index ICU admission following cardiac surgery.
Study Design:
Unblinded randomized controlled trial pilot. Data will be used to inform/justify the feasibility, design, and implementation of a future multi-center randomized controlled trial.
Study Population:
Moderate or high-risk (EuroSCORE II > 2%), non-emergent, adult open-heart cardiac surgery patients. Heart transplant, durable VAD implantation, or patients who require post-operative MCS support will be excluded.
Sample size= 100 (50 control : 50 intervention)
Intervention:
Patients randomized to the intervention arm will be monitored using the HPI technology and be treated following a GDT algorithm when HPI is >50 for 48-hours or duration of invasive arterial monitoring (whichever occurs first). The GDT algorithm is a standardized approach to identifying abnormal hemodynamic parameters and administering a prescribed therapy in a step-wise fashion with fixed re-assessment intervals (see attached).
What will be different from routine care? :
- Hemodynamic interventions (fluid, inotropic, or vasopressor therapy) will be administered when HPI > 50 rather than MAP < 65.
- Choice of applied therapy (fluid, inotropic, or vasopressor therapy) will be guided by a GDT algorithm.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 18 years of age
- Planned cardiac surgery using cardiopulmonary bypass (sternotomy or MICS)
- Preoperative European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) of 2% or more.
- Informed consent obtained.
Exclusion Criteria:
- Patients who refuse participation
- Patients who are unable to give informed consent
- Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
- Emergency surgery
- Patients who require MCS (including ECMO, Impella, or IABP) post-operatively
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Routine post-operative clinical care.
|
|
Experimental: Intervention
Goal-directed therapy algorithm in addition to routine post-operative clinical care.
|
Goal-directed therapy using HemoSphere® monitor, Acumen® transducer, and Hypotension Prediction Index® algorithm (Edwards Lifesciences, Irvine, USA),
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-hour cumulative IV fluid administration
Time Frame: 24-hours
|
Cumulative post-operative intravenous fluid administration over the first 24-hours of index ICU admission.
|
24-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluid Administration
Time Frame: Duration of ICU stay, up to 30-days
|
Daily average
|
Duration of ICU stay, up to 30-days
|
Fluid Administration
Time Frame: Duration of ICU stay, up to 30-days
|
Cumulative
|
Duration of ICU stay, up to 30-days
|
Vasoactive medication administration
Time Frame: Duration of ICU stay, up to 30-days
|
Daily average
|
Duration of ICU stay, up to 30-days
|
Vasoactive medication administration
Time Frame: Duration of ICU stay, up to 30-days
|
Daily cumulative
|
Duration of ICU stay, up to 30-days
|
Vasoactive medication administration
Time Frame: Duration of ICU stay, up to 30-days
|
Duration
|
Duration of ICU stay, up to 30-days
|
Hemodynamic parameters
Time Frame: 48-hours or when arterial line removed
|
Incidence of HPI > 50 greater than 5-minutes
|
48-hours or when arterial line removed
|
Hemodynamic parameters
Time Frame: 48-hours or when arterial line removed
|
Incidence of HPI > 85 greater than 5-minutes
|
48-hours or when arterial line removed
|
Hemodynamic parameters
Time Frame: 48-hours or when arterial line removed
|
Incidence of MAP < 65 greater than 5-minutes
|
48-hours or when arterial line removed
|
Hemodynamic parameters
Time Frame: 24-hours
|
Total Area Under the Curve (AUC) for HPI > 50
|
24-hours
|
Hemodynamic parameters
Time Frame: 48-hours or when arterial line removed
|
Total Area Under the Curve (AUC) for HPI > 50
|
48-hours or when arterial line removed
|
Hemodynamic parameters
Time Frame: 24-hours
|
Total Area Under the Curve (AUC) for HPI > 85
|
24-hours
|
Hemodynamic parameters
Time Frame: 48-hours or when arterial line removed
|
Total Area Under the Curve (AUC) for HPI > 85
|
48-hours or when arterial line removed
|
Hemodynamic parameters
Time Frame: 24-hours
|
Total Area Under the Curve (AUC) for MAP < 65
|
24-hours
|
Hemodynamic parameters
Time Frame: 48-hours or when arterial line removed
|
Total Area Under the Curve (AUC) for MAP < 65
|
48-hours or when arterial line removed
|
Enrollment
Time Frame: 1-year
|
Proportion of screened patients eligible for enrollment.
|
1-year
|
Enrollment
Time Frame: 1-year
|
Proportion of eligible patients who consent to participate.
|
1-year
|
Study Protocol Compliance
Time Frame: 1-year
|
Proportion of consented patients who complete all study assessments.
|
1-year
|
Arterial Monitoring Reliability
Time Frame: 1-year
|
Number of arterial catheters requiring replacement
|
1-year
|
GDT algorithm compliance
Time Frame: 48-hours or when arterial line removed
|
Time from HPI > 50 to application of an intervention
|
48-hours or when arterial line removed
|
GDT algorithm compliance
Time Frame: 48-hours or when arterial line removed
|
Proportion of hemodynamic interventions applied for HPI > 50 that were recommended by the algorithm
|
48-hours or when arterial line removed
|
GDT algorithm compliance
Time Frame: 48-hours or when arterial line removed
|
Proportion of hemodynamic interventions applied for MAP < 65 that would be recommended by the algorithm based on hemodynamic parameters.
|
48-hours or when arterial line removed
|
GDT algorithm compliance
Time Frame: 48-hours or when arterial line removed
|
MD notifications prompted by the GDT algorithm and resulting actions
|
48-hours or when arterial line removed
|
GDT algorithm compliance
Time Frame: 48-hours or when arterial line removed
|
Actions (therapies or investigations) prompted by an MD notification.
|
48-hours or when arterial line removed
|
GDT algorithm compliance
Time Frame: 48-hours or when arterial line removed
|
Number of study protocol suspensions
|
48-hours or when arterial line removed
|
GDT algorithm compliance
Time Frame: 48-hours or when arterial line removed
|
Duration of protocol suspensions
|
48-hours or when arterial line removed
|
GDT algorithm compliance
Time Frame: 48-hours or when arterial line removed
|
Rationale for protocol suspensions
|
48-hours or when arterial line removed
|
End-organ dysfunction/injury
Time Frame: Index admission, up to 30-days
|
Acute kidney injury
|
Index admission, up to 30-days
|
End-organ dysfunction/injury
Time Frame: Index admission, up to 30-days
|
Delirium
|
Index admission, up to 30-days
|
End-organ dysfunction/injury
Time Frame: Index admission, up to 30-days
|
Stroke
|
Index admission, up to 30-days
|
End-organ dysfunction/injury
Time Frame: Index admission, up to 30-days
|
Ileus
|
Index admission, up to 30-days
|
End-organ dysfunction/injury
Time Frame: Index admission, up to 30-days
|
Gut infarction
|
Index admission, up to 30-days
|
End-organ dysfunction/injury
Time Frame: Index admission, up to 30-days
|
Prolonged mechanical ventilation (> 24 hours)
|
Index admission, up to 30-days
|
End-organ dysfunction/injury
Time Frame: Index admission, up to 30-days
|
Deep sternal wound infection
|
Index admission, up to 30-days
|
End-organ dysfunction/injury
Time Frame: Index admission, up to 30-days
|
Any surgical site infection
|
Index admission, up to 30-days
|
Transfusion
Time Frame: Index admission, up to 30-days
|
Total red-blood cell administration
|
Index admission, up to 30-days
|
Transfusion
Time Frame: Index admission, up to 30-days
|
Total fresh-frozen plasma administration
|
Index admission, up to 30-days
|
Transfusion
Time Frame: Index admission, up to 30-days
|
Total platelet administration
|
Index admission, up to 30-days
|
Transfusion
Time Frame: Index admission, up to 30-days
|
Total albumin administration
|
Index admission, up to 30-days
|
Mobilzation
Time Frame: Index admission, up to 30-days
|
Time to first mobilization (dangle)
|
Index admission, up to 30-days
|
Mobilzation
Time Frame: Index admission, up to 30-days
|
Time to first mobilization (stand)
|
Index admission, up to 30-days
|
Mobilization
Time Frame: Index admission, up to 30-days
|
Time to first mobilization (walk)
|
Index admission, up to 30-days
|
Hydration
Time Frame: Index admission, up to 30-days
|
Time to first PO hydration
|
Index admission, up to 30-days
|
Nutrition
Time Frame: Index admission, up to 30-days
|
Time to first PO nutrition
|
Index admission, up to 30-days
|
Patient-centered Outcome
Time Frame: Index admission, up to 10-days
|
Quality of Recovery-15 (QOR-15) at post-op days 3, 5, 7, and 10.
|
Index admission, up to 10-days
|
Patient-centered Outcome
Time Frame: Up to 1-year post-operative
|
World Health Organization Disability Assessment Schedule (WHODAS 2.0) at baseline, 2-weeks, 30-days, 90-days, and 1-year.
|
Up to 1-year post-operative
|
Patient-centered Outcome
Time Frame: Up to 1-year post-operative
|
MacNew Questionnaire at baseline, 2-weeks, 30-days, 90-days, and 1-year.
|
Up to 1-year post-operative
|
Patient-centered Outcome
Time Frame: Up to 1-year post-operative
|
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) at baseline, 2-weeks, 30-days, 90-days, and 1-year.
|
Up to 1-year post-operative
|
Patient-centered Outcome
Time Frame: 30-days
|
Canadian Patient Experiences Survey on Inpatient Care (CPES-IC) at 30-days
|
30-days
|
Length of Stay
Time Frame: Up to 1-year post-operative
|
ICU length of stay
|
Up to 1-year post-operative
|
Length of Stay
Time Frame: Up to 1-year post-operative
|
Hospital length of stay
|
Up to 1-year post-operative
|
Re-admission
Time Frame: 30-days
|
Incidence of hospital re-admission within 30-days of index surgery
|
30-days
|
Mortality
Time Frame: Up to 1-year post-operative
|
7-day, 30-day, and 1-year mortality.
|
Up to 1-year post-operative
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Li P, Qu LP, Qi D, Shen B, Wang YM, Xu JR, Jiang WH, Zhang H, Ding XQ, Teng J. Significance of perioperative goal-directed hemodynamic approach in preventing postoperative complications in patients after cardiac surgery: a meta-analysis and systematic review. Ann Med. 2017 Jun;49(4):343-351. doi: 10.1080/07853890.2016.1271956. Epub 2017 Feb 2.
- Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121.
- Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
- Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.
- Osawa EA, Rhodes A, Landoni G, Galas FR, Fukushima JT, Park CH, Almeida JP, Nakamura RE, Strabelli TM, Pileggi B, Leme AC, Fominskiy E, Sakr Y, Lima M, Franco RA, Chan RP, Piccioni MA, Mendes P, Menezes SR, Bruno T, Gaiotto FA, Lisboa LA, Dallan LA, Hueb AC, Pomerantzeff PM, Kalil Filho R, Jatene FB, Auler Junior JO, Hajjar LA. Effect of Perioperative Goal-Directed Hemodynamic Resuscitation Therapy on Outcomes Following Cardiac Surgery: A Randomized Clinical Trial and Systematic Review. Crit Care Med. 2016 Apr;44(4):724-33. doi: 10.1097/CCM.0000000000001479.
- Shin B, Maler SA, Reddy K, Fleming NW. Use of the Hypotension Prediction Index During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1769-1775. doi: 10.1053/j.jvca.2020.12.025. Epub 2020 Dec 21.
- Parsons H, Zilahi G. Pro: Hypotension Prediction Index-A New Tool to Predict Hypotension in Cardiac Surgery? J Cardiothorac Vasc Anesth. 2023 May 17:S1053-0770(23)00329-4. doi: 10.1053/j.jvca.2023.05.023. Online ahead of print. No abstract available.
- Rellum SR, Schuurmans J, Schenk J, van der Ster BJP, van der Ven WH, Geerts BF, Hollmann MW, Cherpanath TGV, Lagrand WK, Wynandts P, Paulus F, Driessen AHG, Terwindt LE, Eberl S, Hermanns H, Veelo DP, Vlaar APJ. Effect of the machine learning-derived Hypotension Prediction Index (HPI) combined with diagnostic guidance versus standard care on depth and duration of intraoperative and postoperative hypotension in elective cardiac surgery patients: HYPE-2 - study protocol of a randomised clinical trial. BMJ Open. 2023 May 2;13(5):e061832. doi: 10.1136/bmjopen-2022-061832.
- Maheshwari K, Buddi S, Jian Z, Settels J, Shimada T, Cohen B, Sessler DI, Hatib F. Performance of the Hypotension Prediction Index with non-invasive arterial pressure waveforms in non-cardiac surgical patients. J Clin Monit Comput. 2021 Feb;35(1):71-78. doi: 10.1007/s10877-020-00463-5. Epub 2020 Jan 27.
- Baumgarten M, Brodsgaard A, Bunkenborg G, Foss NB, Norholm V. Nurse and Physician Perceptions of Working With Goal-Directed Therapy in the Perioperative Period. J Perianesth Nurs. 2020 Apr;35(2):198-205. doi: 10.1016/j.jopan.2019.09.005. Epub 2019 Dec 13.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REB23-0043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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