Goal-Directed Therapy Following Cardiac Surgery

Surgery Clinical Trial

Official title:

Goal-Directed Therapy (GDT) Using Hypotension Prediction Index (HPI) Following Cardiac Surgery: a Pilot Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05964374
• Other study ID #: REB23-0043
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot prospective randomized control trial comparing goal-directed therapy algorithm vs routine care in the intensive care unit following cardiac surgery.

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? :

1. Hemodynamic interventions (fluid, inotropic, or vasopressor therapy) will be administered when HPI > 50 rather than MAP < 65.

2. Choice of applied therapy (fluid, inotropic, or vasopressor therapy) will be guided by a GDT algorithm.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. = 18 years of age

2. Planned cardiac surgery using cardiopulmonary bypass (sternotomy or MICS)

3. Preoperative European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) of 2% or more.

4. Informed consent obtained.

Exclusion Criteria:

1. Patients who refuse participation

2. Patients who are unable to give informed consent

3. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device

4. Emergency surgery

5. Patients who require MCS (including ECMO, Impella, or IABP) post-operatively

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Goal-directed therapy
Goal-directed therapy using HemoSphere® monitor, Acumen® transducer, and Hypotension Prediction Index® algorithm (Edwards Lifesciences, Irvine, USA),

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	University of Alberta

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour cumulative IV fluid administration	Cumulative post-operative intravenous fluid administration over the first 24-hours of index ICU admission.	24-hours
Secondary	Fluid Administration	Daily average	Duration of ICU stay, up to 30-days
Secondary	Fluid Administration	Cumulative	Duration of ICU stay, up to 30-days
Secondary	Vasoactive medication administration	Daily average	Duration of ICU stay, up to 30-days
Secondary	Vasoactive medication administration	Daily cumulative	Duration of ICU stay, up to 30-days
Secondary	Vasoactive medication administration	Duration	Duration of ICU stay, up to 30-days
Secondary	Hemodynamic parameters	Incidence of HPI > 50 greater than 5-minutes	48-hours or when arterial line removed
Secondary	Hemodynamic parameters	Incidence of HPI > 85 greater than 5-minutes	48-hours or when arterial line removed
Secondary	Hemodynamic parameters	Incidence of MAP < 65 greater than 5-minutes	48-hours or when arterial line removed
Secondary	Hemodynamic parameters	Total Area Under the Curve (AUC) for HPI > 50	24-hours
Secondary	Hemodynamic parameters	Total Area Under the Curve (AUC) for HPI > 50	48-hours or when arterial line removed
Secondary	Hemodynamic parameters	Total Area Under the Curve (AUC) for HPI > 85	24-hours
Secondary	Hemodynamic parameters	Total Area Under the Curve (AUC) for HPI > 85	48-hours or when arterial line removed
Secondary	Hemodynamic parameters	Total Area Under the Curve (AUC) for MAP < 65	24-hours
Secondary	Hemodynamic parameters	Total Area Under the Curve (AUC) for MAP < 65	48-hours or when arterial line removed
Secondary	Enrollment	Proportion of screened patients eligible for enrollment.	1-year
Secondary	Enrollment	Proportion of eligible patients who consent to participate.	1-year
Secondary	Study Protocol Compliance	Proportion of consented patients who complete all study assessments.	1-year
Secondary	Arterial Monitoring Reliability	Number of arterial catheters requiring replacement	1-year
Secondary	GDT algorithm compliance	Time from HPI > 50 to application of an intervention	48-hours or when arterial line removed
Secondary	GDT algorithm compliance	Proportion of hemodynamic interventions applied for HPI > 50 that were recommended by the algorithm	48-hours or when arterial line removed
Secondary	GDT algorithm compliance	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
Secondary	GDT algorithm compliance	MD notifications prompted by the GDT algorithm and resulting actions	48-hours or when arterial line removed
Secondary	GDT algorithm compliance	Actions (therapies or investigations) prompted by an MD notification.	48-hours or when arterial line removed
Secondary	GDT algorithm compliance	Number of study protocol suspensions	48-hours or when arterial line removed
Secondary	GDT algorithm compliance	Duration of protocol suspensions	48-hours or when arterial line removed
Secondary	GDT algorithm compliance	Rationale for protocol suspensions	48-hours or when arterial line removed
Secondary	End-organ dysfunction/injury	Acute kidney injury	Index admission, up to 30-days
Secondary	End-organ dysfunction/injury	Delirium	Index admission, up to 30-days
Secondary	End-organ dysfunction/injury	Stroke	Index admission, up to 30-days
Secondary	End-organ dysfunction/injury	Ileus	Index admission, up to 30-days
Secondary	End-organ dysfunction/injury	Gut infarction	Index admission, up to 30-days
Secondary	End-organ dysfunction/injury	Prolonged mechanical ventilation (> 24 hours)	Index admission, up to 30-days
Secondary	End-organ dysfunction/injury	Deep sternal wound infection	Index admission, up to 30-days
Secondary	End-organ dysfunction/injury	Any surgical site infection	Index admission, up to 30-days
Secondary	Transfusion	Total red-blood cell administration	Index admission, up to 30-days
Secondary	Transfusion	Total fresh-frozen plasma administration	Index admission, up to 30-days
Secondary	Transfusion	Total platelet administration	Index admission, up to 30-days
Secondary	Transfusion	Total albumin administration	Index admission, up to 30-days
Secondary	Mobilzation	Time to first mobilization (dangle)	Index admission, up to 30-days
Secondary	Mobilzation	Time to first mobilization (stand)	Index admission, up to 30-days
Secondary	Mobilization	Time to first mobilization (walk)	Index admission, up to 30-days
Secondary	Hydration	Time to first PO hydration	Index admission, up to 30-days
Secondary	Nutrition	Time to first PO nutrition	Index admission, up to 30-days
Secondary	Patient-centered Outcome	Quality of Recovery-15 (QOR-15) at post-op days 3, 5, 7, and 10.	Index admission, up to 10-days
Secondary	Patient-centered Outcome	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
Secondary	Patient-centered Outcome	MacNew Questionnaire at baseline, 2-weeks, 30-days, 90-days, and 1-year.	Up to 1-year post-operative
Secondary	Patient-centered Outcome	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
Secondary	Patient-centered Outcome	Canadian Patient Experiences Survey on Inpatient Care (CPES-IC) at 30-days	30-days
Secondary	Length of Stay	ICU length of stay	Up to 1-year post-operative
Secondary	Length of Stay	Hospital length of stay	Up to 1-year post-operative
Secondary	Re-admission	Incidence of hospital re-admission within 30-days of index surgery	30-days
Secondary	Mortality	7-day, 30-day, and 1-year mortality.	Up to 1-year post-operative