SurgeryNCT05964374
Goal-Directed Therapy Following Cardiac Surgery
A study testing Goal-directed therapy in people with Surgery, run by University of Calgary at 1 site in Canada.
Trial summary
Pilot prospective randomized control trial comparing goal-directed therapy algorithm vs routine care in the intensive care unit following cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Surgery
- What is being tested?
- Goal-directed therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- Emergency surgery
- Patients who refuse participation
- Patients who are unable to give informed consent
- Patients who are having a heart or lung transplant.
- Surgery for insertion of any ventricular assist device
- Aortic arch procedures with any degree of debranching or hybrid with endovascular intervention in the ascending aorta +/- arch.
Show all 11Show fewer
- Patients who require MCS (including ECMO, Impella, or IABP) post-operatively
- Patients on contact/droplet isolation.
- Patients deemed excessively unstable and/or complex by their attending intensivist on arrival to the ICU.
- If the post-operative arterial line MAP goal is not 65 mmHg.
- Patients who suffer intra-operative mortality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal-Directed Therapy (GDT) Using Hypotension Prediction Index (HPI) Following Cardiac Surgery: a Pilot Randomized Control Trial
Pilot prospective randomized control trial comparing goal-directed therapy algorithm vs routine care in the intensive care unit following cardiac surgery.
Read the 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.
- Conditions
- Surgery
- Being tested
- Goal-directed therapy
- Keywords
- cardiac surgery, hemodynamic optimization, goal-directed therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed therapyDevice
Goal-directed therapy using HemoSphere® monitor, Acumen® transducer, and Hypotension Prediction Index® algorithm (Edwards Lifesciences, Irvine, USA),
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine post-operative clinical care. |
| Intervention | Experimental | Goal-directed therapy algorithm in addition to routine post-operative clinical care. Receives: Device: Goal-directed therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour cumulative IV fluid administration
Cumulative post-operative intravenous fluid administration over the first 24-hours of index ICU admission.
Measured: 24-hours
Secondary outcomes (52)
Fluid Administration
Daily average
Measured: Duration of ICU stay, up to 30-days
Fluid Administration
Cumulative
Measured: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Daily average
Measured: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Daily cumulative
Measured: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Duration
Measured: Duration of ICU stay, up to 30-days
Hemodynamic parameters
Incidence of HPI > 50 greater than 5-minutes
Measured: 48-hours or when arterial line removed
Hemodynamic parameters
Incidence of HPI > 85 greater than 5-minutes
Measured: 48-hours or when arterial line removed
Hemodynamic parameters
Incidence of MAP < 65 greater than 5-minutes
Measured: 48-hours or when arterial line removed
Hemodynamic parameters
Total Area Under the Curve (AUC) for HPI > 50
Measured: 24-hours
Hemodynamic parameters
Total Area Under the Curve (AUC) for HPI > 50
Measured: 48-hours or when arterial line removed
Hemodynamic parameters
Total Area Under the Curve (AUC) for HPI > 85
Measured: 24-hours
Hemodynamic parameters
Total Area Under the Curve (AUC) for HPI > 85
Measured: 48-hours or when arterial line removed
Hemodynamic parameters
Total Area Under the Curve (AUC) for MAP < 65
Measured: 24-hours
Hemodynamic parameters
Total Area Under the Curve (AUC) for MAP < 65
Measured: 48-hours or when arterial line removed
Enrollment
Proportion of screened patients eligible for enrollment.
Measured: 1-year
Enrollment
Proportion of eligible patients who consent to participate.
Measured: 1-year
Study Protocol Compliance
Proportion of consented patients who complete all study assessments.
Measured: 1-year
Arterial Monitoring Reliability
Number of arterial catheters requiring replacement
Measured: 1-year
GDT algorithm compliance
Time from HPI > 50 to application of an intervention
Measured: 48-hours or when arterial line removed
GDT algorithm compliance
Proportion of hemodynamic interventions applied for HPI > 50 that were recommended by the algorithm
Measured: 48-hours or when arterial line removed
GDT algorithm compliance
Proportion of hemodynamic interventions applied for MAP < 65 that would be recommended by the algorithm based on hemodynamic parameters.
Measured: 48-hours or when arterial line removed
GDT algorithm compliance
MD notifications prompted by the GDT algorithm and resulting actions
Measured: 48-hours or when arterial line removed
GDT algorithm compliance
Actions (therapies or investigations) prompted by an MD notification.
Measured: 48-hours or when arterial line removed
GDT algorithm compliance
Number of study protocol suspensions
Measured: 48-hours or when arterial line removed
GDT algorithm compliance
Duration of protocol suspensions
Measured: 48-hours or when arterial line removed
GDT algorithm compliance
Rationale for protocol suspensions
Measured: 48-hours or when arterial line removed
End-organ dysfunction/injury
Acute kidney injury
Measured: Index admission, up to 30-days
End-organ dysfunction/injury
Delirium
Measured: Index admission, up to 30-days
End-organ dysfunction/injury
Stroke
Measured: Index admission, up to 30-days
End-organ dysfunction/injury
Ileus
Measured: Index admission, up to 30-days
End-organ dysfunction/injury
Gut infarction
Measured: Index admission, up to 30-days
End-organ dysfunction/injury
Prolonged mechanical ventilation (> 24 hours)
Measured: Index admission, up to 30-days
End-organ dysfunction/injury
Deep sternal wound infection
Measured: Index admission, up to 30-days
End-organ dysfunction/injury
Any surgical site infection
Measured: Index admission, up to 30-days
Transfusion
Total red-blood cell administration
Measured: Index admission, up to 30-days
Transfusion
Total fresh-frozen plasma administration
Measured: Index admission, up to 30-days
Transfusion
Total platelet administration
Measured: Index admission, up to 30-days
Transfusion
Total albumin administration
Measured: Index admission, up to 30-days
Mobilzation
Time to first mobilization (dangle)
Measured: Index admission, up to 30-days
Mobilzation
Time to first mobilization (stand)
Measured: Index admission, up to 30-days
Mobilization
Time to first mobilization (walk)
Measured: Index admission, up to 30-days
Hydration
Time to first PO hydration
Measured: Index admission, up to 30-days
Nutrition
Time to first PO nutrition
Measured: Index admission, up to 30-days
Patient-centered Outcome
Quality of Recovery-15 (QOR-15) at post-op days 3, 5, 7, and 10.
Measured: Index admission, up to 10-days
Patient-centered Outcome
World Health Organization Disability Assessment Schedule (WHODAS 2.0) at baseline, 2-weeks, 30-days, 90-days, and 1-year.
Measured: Up to 1-year post-operative
Patient-centered Outcome
MacNew Questionnaire at baseline, 2-weeks, 30-days, 90-days, and 1-year.
Measured: Up to 1-year post-operative
Patient-centered Outcome
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) at baseline, 2-weeks, 30-days, 90-days, and 1-year.
Measured: Up to 1-year post-operative
Patient-centered Outcome
Canadian Patient Experiences Survey on Inpatient Care (CPES-IC) at 30-days
Measured: 30-days
Length of Stay
ICU length of stay
Measured: Up to 1-year post-operative
Length of Stay
Hospital length of stay
Measured: Up to 1-year post-operative
Re-admission
Incidence of hospital re-admission within 30-days of index surgery
Measured: 30-days
Mortality
7-day, 30-day, and 1-year mortality.
Measured: Up to 1-year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Nov 2023
- Primary completion15 Aug 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964374
- Sponsor's protocol ID
- REB23-0043
- Status last verified
- May 2026
- First submitted
- 21 Jun 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27936959Osawa 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.
PubMed 26646462Engelman 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.
PubMed 31054241Hatib 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.
PubMed 29894315Davies 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.
PubMed 30896602Shin 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.
PubMed 33446404Parsons 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.
PubMed 37301700Rellum 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.
PubMed 37130670Maheshwari 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.
PubMed 31989416Baumgarten 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.
PubMed 31843240
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-Directed Therapy (GDT) Using Hypotension Prediction Index (HPI) Following Cardiac Surgery: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05964374
- Acronym / sponsor ID
- REB23-0043
- Conditions
- Surgery
- Keywords
- cardiac surgery, hemodynamic optimization, goal-directed therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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? :
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine post-operative clinical care. |
| Intervention | Experimental | Device: Goal-directed therapyGoal-directed therapy algorithm in addition to routine post-operative clinical care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (11 listed)
- Emergency surgery
- Patients who refuse participation
- Patients who are unable to give informed consent
- Patients who are having a heart or lung transplant.
- Surgery for insertion of any ventricular assist device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-directed therapyGoal-directed therapy using HemoSphere® monitor, Acumen® transducer, and Hypotension Prediction Index® algorithm (Edwards Lifesciences, Irvine, USA), | Device | Intervention |
Primary outcome
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.
52 secondary outcomes
Fluid Administration
Time frame: Duration of ICU stay, up to 30-days
Fluid Administration
Time frame: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Time frame: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Time frame: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Time frame: Duration of ICU stay, up to 30-days
Hemodynamic parameters
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Time frame: 24-hours
Hemodynamic parameters
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Time frame: 24-hours
Hemodynamic parameters
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Time frame: 24-hours
Hemodynamic parameters
Time frame: 48-hours or when arterial line removed
Enrollment
Time frame: 1-year
Enrollment
Time frame: 1-year
Study Protocol Compliance
Time frame: 1-year
Arterial Monitoring Reliability
Time frame: 1-year
GDT algorithm compliance
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Time frame: 48-hours or when arterial line removed
End-organ dysfunction/injury
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Time frame: Index admission, up to 30-days
Transfusion
Time frame: Index admission, up to 30-days
Transfusion
Time frame: Index admission, up to 30-days
Transfusion
Time frame: Index admission, up to 30-days
Transfusion
Time frame: Index admission, up to 30-days
Mobilzation
Time frame: Index admission, up to 30-days
Mobilzation
Time frame: Index admission, up to 30-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 27936959Li 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.
- Background: PubMed 26646462Osawa 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.
- Background: PubMed 31054241Engelman 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.
- Background: PubMed 29894315Hatib 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.
- Background: PubMed 30896602Davies 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.
- Background: PubMed 33446404Shin 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.
- Background: PubMed 37301700Parsons 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.
- Background: PubMed 37130670Rellum 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.
- Background: PubMed 31989416Maheshwari 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.
- Background: PubMed 31843240Baumgarten 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed therapy in people with Surgery, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour cumulative IV fluid administration (time frame: 24-hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964374, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.