El DORADO STUDY (Evaluation of Delivery of Oxygen on Renal, Arrhythmia and Delirium Outcomes Study)

July 24, 2023 updated by: National University Hospital, Singapore

The study aims to develop a novel perioperative noninvasive delivery of oxygen (DO2) and hemodynamic index in the prediction of postoperative outcomes including post-operative acute kidney injury (POAKI), perioperative neurological cognitive disorders (PONCD) and post-operative atrial fibrillation (POAF).

Our study also aims to study the effect of DO2 and hemodynamic parameters (measured noninvasively) on the development of PONCD, POAF and POAKI in cardiac surgical patients. We aim to develop a novel DO2 index and hemodynamic index predictive of PONCD, POAF and POAKI.

The secondary aim would be to develop real-time machine learning aided algorithms in the analysis of noninvasive continuous hemodynamic and DO2 data, to predict and guide perioperative treatment of POCND, POAF and POAKI in the perioperative setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative acute kidney injury, AF and neurocognitive disorders (POAKI, POAF and PONCD) are common complications post cardiac surgery. Postoperative neurocognitive disorders occur in up to 73% of cardiac surgical patients, while our previous studies have demonstrated the incidence of POAF and POAKI to be 14.7% and 29.9% respectively. These perioperative complications have been shown to be associated with adverse short and long term outcomes. Apart from increased hospital length of stay and mortality, their adverse effects also extend far beyond the acute perioperative period of insult. Postoperative AKI has been shown to be associated with progression to long term renal dysfunction. Postoperative atrial fibrillation was initially thought to be a benign phenomenon, however, it has been shown to be associated with increased risk of long term stroke and mortality (Hazards Ratio 1.26 and 1.2 respectively). Postoperative delirium has is also associated with accelerated cognitive decline in Alzheimer's patients, long term cognitive decline, dementia and functional decline after discharge to the community. These phenomena remain ever pertinent in the setting of high risk and aging surgical patients, and thus need to be addressed.

The need for hemodynamic optimisation and goal directed therapy remains central to current care standards in anesthesia. This highlights the need for the quantification and improvement of cardiac output and more recently, the emerging focus on perioperative oxygen delivery (DO2) in improving clinical outcomes. Oxygen delivery can be calculated based on the oxygen flux equation: DO2 = CO x (Hb x SaO2 x 1.36); this concept of optimizing systemic oxygen delivery rather than hemodynamic parameters alone has been increasingly studied in recent times. Emerging studies involving patients undergoing cardiopulmonary bypass (CPB) have demonstrated the optimization of DO2, nadir DO2 and duration below optimum DO2 to be the most specific factors of postoperative AKI . The importance of optimizing DO2 in improving clinical outcomes is also evidenced in the critical care period, where Raimundo et al recently demonstrated that patents with a mean DO2 Index of 325ml/min/m2 were at significant risk of developing AKI which progressed to chronic renal failure, as opposed to patients who maintained a mean DO2 Index of >405ml/min/m2 . The utility of optimizing DO2 in the avoidance of postoperative delirium and atrial fibrillation however remain unknown, with previous studies being retrospective, small in sample size with conflicting results.

The use of invasive hemodynamic monitoring has been used extensively in the development of perioperative goal directed therapy protocols and hemodynamic optimization. Parameters such as MAP, CI and SVV are commonplace in the operative and ICU settings, and are used to titrate fluid, vasopressor and inotrope use. However, a delicate balance between pressure (CI, MAP) and flow (SVRI) exists in systemic organ perfusion, which may be translated into clinical outcomes such as POAF, POAKI and PONCD. Separate studies have demonstrated variations in vascular resistance to be associated with increased risk of postoperative delirium and AKI, despite the maintenance of high MAP levels. These studies indicate the possible inadequacy of MAP as the sole marker of systemic organ perfusion, and the need for further hemodynamic parameters to be studied. Our study would be the first to investigate the interplay between these SVV, SVRI, CI and MAP using non-invasive hemodynamic monitoring techniques.

In the past, this monitoring of continuous hemodynamics required invasive lines, while the continuous monitoring of DO2 was previously impossible. The use of invasive lines has been associated with multiple complications including infection, thrombosis and vascular aneurysms, while continuous DO2 monitoring would involve continuous point of care testing of hemoglobin which is impractical. Therefore, the risk benefit ratio of placing invasive lines remains controversial particularly in the routine well patient who however remains at risk of perioperative complications.

The advent of new technology has allowed for the real-time noninvasive continuous individual measurement of hemodynamics and oxygen delivery. We propose the integration of 2 new devices so as to provide the continuous noninvasive monitoring of hemodynamic data and real-time noninvasive hemoglobin and oxygen saturation - the combination of which would enable us to calculate real time systemic oxygen delivery. Continuous noninvasive hemodynamic data (the Edwards Clearsight) is based on oscillonometry and the Penaz technique which has been historically established and used in clinical practice. Continuous noninvasive hemoglobin and oxygen saturation monitoring (the Masimo SET) has been validated, and is based on established principles of spectrophotometry, oximetry and the beer lambert's law . With technological improvements over the years, these noninvasive devices have been individually evaluated against clinical gold standards in multiple studies and found to be clinically applicable in predicting perioperative hemoglobin and hemodynamic trends . Therefore, we propose the novel integrated use of these two devices in deriving a real-time noninvasive DO2 and hemodynamic index predictive of postoperative atrial fibrillation, AKI and cognitive dysfunction in cardiac surgical patients.

The integrated use of a noninvasive DO2 and hemodynamic index has yet to be studied in the context of POAF, POAKI and PONCD. Data obtained through our study may facilitate the development of new integrative technology, paving the way for the development of single index which can predict organ specific perfusion. This rich source of continuous noninvasive data will be used in the development of algorithms and mathematical models in machine learning. This would allow for the provision of precise goal directed therapy to moderate or high-risk surgical patients, especially beneficial to the geriatric setting. The potential reductions in POAF, PONCD and POAKI achieved through the clinical application of our study findings confer significant perioperative benefits which extend into the community health setting due to the long-term sequelae of these diseases.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore
      • Singapore, Singapore
        • Not yet recruiting
        • National University Hospital
        • Contact:
        • Principal Investigator:
          • Ming Ann Sim
        • Contact:
        • Sub-Investigator:
          • Lian Kah Ti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective cardiac surgery and age above 21 years old.

Description

Inclusion Criteria:

  • Undergoing elective cardiac surgery such as valve replacements or CABG
  • Age above 21 years old
  • Ability to provide informed consent

Exclusion Criteria:

  • Emergency cardiac cases
  • Patients on IABP postoperatively
  • Patients who decline to participate in this study
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical Cohort
Placement of Edwards ClearSight and Masimo SET on patient intraoperatively.
Device: Edwards ClearSight and Masimo SET
Placement of Edwards ClearSight and Masimo SET on the patient intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the incidence of primary outcomes of AKI, POAF and PONCD
Time Frame: Preoperative through to 90 days postoperatively
Collection of patient's demographics, medical records, surgical records and noninvasive hemodynamic data
Preoperative through to 90 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Ming Ann Sim, National University Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/00022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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