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NCT Number: NCT05344573

Optimizing Pulsatility During Cardiopulmonary Bypass

Cardiopulmonary bypass during cardiac surgery provides blood flow to the body during surgery but has adverse effects on different organs. Blood flow during cardiopulmonary bypass may be pulsatile or non-pulsatile, which may impact normal organ function after surgery. The study will collect data on the type of cardiopulmonary bypass used during surgery and organ function to determine if there is an association between the type of bypass and organ function.

Recruiting

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Nathan Clendenen, MD MS

CONTACT

[email protected]

303-724-5000

Nathan J Clendenen, MD MS

PRINCIPAL_INVESTIGATOR

About this study

Cardiac surgery is a high-risk elective surgical procedure frequently requiring CPB in which a machine pumps blood while the surgeon operates on the heart. CPB contributes to surgical risk by causing endothelial dysfunction and acute kidney injury (AKI). Endothelial dysfunction and AKI happen because heart lung machines typically generate non-pulsatile blood flow, which is abnormal and results in impaired tissue oxygen delivery. Normal blood flow is pulsatile due intermittent contraction and relaxation of the heart during the cardiac cycle, which produces a mechanical signal that induces endothelial cells to produce nitric oxide. Without nitric oxide, blood flow does not penetrate as deeply into organs such as the kidneys which leads to acute kidney injury. AKI increases mortality 10-fold after cardiac surgery placing many people at risk since over 400,000 people have surgery with CPB each year in the United States. Thus, pulsatile CPB may influence endothelial function and renal blood flow after cardiac surgery. This study will observe patients undergoing cardiac surgery with CPB and compare patients who receive pulsatile or non-pulsatile CPB.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50 to 70
  • Able to provide informed consent
  • Scheduled for elective cardiac surgery with cardiopulmonary bypass

Exclusion criteria

  • Patients undergoing emergency procedures
  • Diagnosed with sepsis
  • Experiencing delirium
  • Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
  • Patients with a mechanical circulatory support device
  • Requiring vasoactive medications before surgery
  • Patients with a reduced left ventricular ejection fraction (less than 50%)
  • Patients with a contraindication to transesophageal echocardiography

Treatment and study plan

Primary outcomes

  1. Endothelial function

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Percent change in flow mediated dilation of the brachial artery after cardiac surgery

Secondary outcomes

  1. Acute kidney injury

    Time frame: From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days

    Acute kidney injury by the KDIGO criteria

  2. Renal blood flow velocity

    Time frame: Intra-operative time point: after cardiopulmonary bypass, up to 12 hours

    Renal blood flow velocity measured by pulse wave doppler

  3. Acute kidney injury risk

    Time frame: Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours

    Acute kidney injury risk measured by urinary TIMP2*IGFBP7

  4. Perioperative death

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Death after surgery during the surgical hospital encounter

  5. Myocardial infarction

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Myocardial infarction after surgery

  6. Stroke

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Stroke after surgery

  7. New renal failure requiring renal replacement therapy

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    New renal failure requiring renal replacement therapy after surgery

  8. Re-exploration for bleeding

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Need for surgical re-exploration to control hemorrhage

  9. Post-operative sepsis

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative sepsis determined by positive blood culture

  10. New onset atrial fibrillation

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative new onset atrial fibrillation

  11. Post-operative blood loss

    Time frame: From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours

    Post-operative blood loss determined by total surgical drain output

  12. Duration of mechanical ventilation

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Duration of mechanical ventilation after surgery

  13. Post-operative delirium

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative delirium determined by the Confusion Assessment Method for the Intensive Care Unit score

  14. Post-operative hospital length of stay

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Duration of hospital stay after surgery

  15. New requirement for mechanical circulatory support

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative initiation of mechanical circulatory support

  16. Intra-operative red blood cell transfusion

    Time frame: During the intra-operative time period, up to 12 hours

    Intra-operative red blood cell transfusion in units

  17. Post-operative red blood cell transfusion

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative red blood cell transfusion in units

  18. Post-operative platelet transfusion

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative platelet transfusion in units

  19. Post-operative plasma transfusion

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative plasma transfusion in units

  20. Post-operative cryoprecipitate transfusion

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Post-operative cryoprecipitate transfusion in units

  21. Intra-operative platelet transfusion

    Time frame: During the intra-operative time period, up to 12 hours

    Intra-operative platelet transfusion in units

  22. Intra-operative plasma transfusion

    Time frame: During the intra-operative time period, up to 12 hours

    Intra-operative plasma transfusion in units

  23. Intra-operative cryoprecipitate transfusion

    Time frame: During the intra-operative time period, up to 12 hours

    Intra-operative cryoprecipitate transfusion in units

  24. Glycocalyx thickness

    Time frame: Start of the intra-operative period to 24 hours after intensive care unit admission

    Glycocalyx thickness determined by sublingual microcirculation microscopy

  25. Microvascular circulatory function

    Time frame: Start of the intra-operative period to 24 hours after intensive care unit admission

    Microvascular circulatory function determined by sublingual microcirculation microscopy

  26. New onset of acute lung injury

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Diagnosis of acute lung injury by PaO2 to FiO2 ratio

  27. New onset of left ventricular diastolic dysfunction

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    Diagnosis new onset diastolic dysfunction by annular e' velocity: septal e' < 7 cm/sec, lateral e' <10 cm/sec, average E/e' ratio > 14, LA volume index > 34 mL/m2, and peak TR velocity > 2.8 m/sec.

  28. New onset of left ventricular systolic dysfunction

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    New onset of left ventricular systolic dysfunction determined by a LV ejection fraction <50%

  29. New onset of right ventricular systolic dysfunction

    Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days

    New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm

Study contacts

Contact information is provided by the study sponsor or research team.

Nathan J Clendenen, MD, MS

CONTACT

[email protected]

(303) 724-5375

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 25, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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