Clinical trial NCT05964374: Goal-Directed Therapy Following Cardiac Surgery
Official title: Goal-Directed Therapy (GDT) Using Hypotension Prediction Index (HPI) Following Cardiac Surgery: a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Keywords: cardiac surgery
hemodynamic optimization
goal-directed therapy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
First posted: 2023-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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? :

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.

Eligibility criteria: 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

Primary outcomes:
measure: 24-hour cumulative IV fluid administration
timeFrame: 24-hours
Secondary outcomes:
measure: Fluid Administration
timeFrame: Duration of ICU stay, up to 30-days
measure: Fluid Administration
timeFrame: Duration of ICU stay, up to 30-days
measure: Vasoactive medication administration
timeFrame: Duration of ICU stay, up to 30-days
measure: Vasoactive medication administration
timeFrame: Duration of ICU stay, up to 30-days
measure: Vasoactive medication administration
timeFrame: Duration of ICU stay, up to 30-days
measure: Hemodynamic parameters
timeFrame: 48-hours or when arterial line removed
measure: Hemodynamic parameters
timeFrame: 48-hours or when arterial line removed
measure: Hemodynamic parameters
timeFrame: 48-hours or when arterial line removed
measure: Hemodynamic parameters
timeFrame: 24-hours
measure: Hemodynamic parameters
timeFrame: 48-hours or when arterial line removed
measure: Hemodynamic parameters
timeFrame: 24-hours
measure: Hemodynamic parameters
timeFrame: 48-hours or when arterial line removed
measure: Hemodynamic parameters
timeFrame: 24-hours
measure: Hemodynamic parameters
timeFrame: 48-hours or when arterial line removed
measure: Enrollment
timeFrame: 1-year
measure: Enrollment
timeFrame: 1-year
measure: Study Protocol Compliance
timeFrame: 1-year
measure: Arterial Monitoring Reliability
timeFrame: 1-year
measure: GDT algorithm compliance
timeFrame: 48-hours or when arterial line removed
measure: GDT algorithm compliance
timeFrame: 48-hours or when arterial line removed
measure: GDT algorithm compliance
timeFrame: 48-hours or when arterial line removed
measure: GDT algorithm compliance
timeFrame: 48-hours or when arterial line removed
measure: GDT algorithm compliance
timeFrame: 48-hours or when arterial line removed
measure: GDT algorithm compliance
timeFrame: 48-hours or when arterial line removed
measure: GDT algorithm compliance
timeFrame: 48-hours or when arterial line removed
measure: GDT algorithm compliance
timeFrame: 48-hours or when arterial line removed
measure: End-organ dysfunction/injury
timeFrame: Index admission, up to 30-days
measure: End-organ dysfunction/injury
timeFrame: Index admission, up to 30-days
measure: End-organ dysfunction/injury
timeFrame: Index admission, up to 30-days
measure: End-organ dysfunction/injury
timeFrame: Index admission, up to 30-days
measure: End-organ dysfunction/injury
timeFrame: Index admission, up to 30-days
measure: End-organ dysfunction/injury
timeFrame: Index admission, up to 30-days
measure: End-organ dysfunction/injury
timeFrame: Index admission, up to 30-days
measure: End-organ dysfunction/injury
timeFrame: Index admission, up to 30-days
measure: Transfusion
timeFrame: Index admission, up to 30-days
measure: Transfusion
timeFrame: Index admission, up to 30-days
measure: Transfusion
timeFrame: Index admission, up to 30-days
measure: Transfusion
timeFrame: Index admission, up to 30-days
measure: Mobilzation
timeFrame: Index admission, up to 30-days
measure: Mobilzation
timeFrame: Index admission, up to 30-days
measure: Mobilization
timeFrame: Index admission, up to 30-days
measure: Hydration
timeFrame: Index admission, up to 30-days
measure: Nutrition
timeFrame: Index admission, up to 30-days
measure: Patient-centered Outcome
timeFrame: Index admission, up to 10-days
measure: Patient-centered Outcome
timeFrame: Up to 1-year post-operative
measure: Patient-centered Outcome
timeFrame: Up to 1-year post-operative
measure: Patient-centered Outcome
timeFrame: Up to 1-year post-operative
measure: Patient-centered Outcome
timeFrame: 30-days
measure: Length of Stay
timeFrame: Up to 1-year post-operative
measure: Length of Stay
timeFrame: Up to 1-year post-operative
measure: Re-admission
timeFrame: 30-days
measure: Mortality
timeFrame: Up to 1-year post-operative
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.
citation: Parsons H, Zilahi G. Pro: Hypotension Prediction Index-A New Tool to Predict Hypotension in Cardiac Surgery? J Cardiothorac Vasc Anesth. 2023 Oct;37(10):2133-2136. doi: 10.1053/j.jvca.2023.05.023. Epub 2023 May 17. No abstract available.
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.
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.
citation: 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.