NCT05964374

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable surgery

Status
unknown

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

June 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 27, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 21, 2023

Last Update Submit

July 19, 2023

Conditions

Surgery

Keywords

cardiac surgeryhemodynamic optimizationgoal-directed therapy

Outcome Measures

Primary Outcomes (1)

  • 24-hour cumulative IV fluid administration

    Cumulative post-operative intravenous fluid administration over the first 24-hours of index ICU admission.

    24-hours

Secondary Outcomes (52)

  • Fluid Administration

    Duration of ICU stay, up to 30-days

  • Fluid Administration

    Duration of ICU stay, up to 30-days

  • Vasoactive medication administration

    Duration of ICU stay, up to 30-days

  • Vasoactive medication administration

    Duration of ICU stay, up to 30-days

  • Vasoactive medication administration

    Duration of ICU stay, up to 30-days

  • +47 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Routine post-operative clinical care.

Intervention

EXPERIMENTAL

Goal-directed therapy algorithm in addition to routine post-operative clinical care.

Device: Goal-directed therapy

Interventions

Goal-directed therapyDEVICE

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

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 27936959BACKGROUND

  • 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.

    PMID: 26646462BACKGROUND

  • 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.

    PMID: 31054241BACKGROUND

  • 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.

    PMID: 29894315BACKGROUND

  • 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.

    PMID: 30896602BACKGROUND

  • 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.

    PMID: 33446404BACKGROUND

  • 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.

    PMID: 37301700BACKGROUND

  • 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.

    PMID: 37130670BACKGROUND

  • 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.

    PMID: 31989416BACKGROUND

  • 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.

    PMID: 31843240BACKGROUND

MeSH Terms

Interventions

Early Goal-Directed Therapy

Intervention Hierarchy (Ancestors)

Critical CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 27, 2023

Study Start

July 1, 2023

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

July 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share