Endothelial DysfunctionNCT05344573
Optimizing Pulsatility During Cardiopulmonary Bypass
An observational study of Endothelial Dysfunction and Acute Kidney Injury, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Endothelial Dysfunction, Acute Kidney Injury
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 50 to 70 years scheduled for elective cardiac surgery with cardiopulmonary bypass
Who may be able to join
- Age 50 to 70
- Able to provide informed consent
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Nathan Clendenen, MD MS, 303-724-5000, nathan.clendenen@cuanschutz.edu
Nathan J Clendenen, MD MS
About this study
Official title: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Endothelial Dysfunction, Acute Kidney Injury
- Keywords
- Endothelial function, Acute Kidney Injury, Cardiopulmonary bypass, Cardiac surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-pulsatile cardiopulmonary bypass | Subjects who undergo cardiac surgery with non-pulsatile cardiopulmonary bypass | |
| Pulsatile cardiopulmonary bypass | Subjects who undergo cardiac surgery with pulsatile cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Percent change in flow mediated dilation of the brachial artery after cardiac surgery
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Secondary outcomes (29)
Acute kidney injury
Acute kidney injury by the KDIGO criteria
Measured: From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days
Renal blood flow velocity
Renal blood flow velocity measured by pulse wave doppler
Measured: Intra-operative time point: after cardiopulmonary bypass, up to 12 hours
Acute kidney injury risk
Acute kidney injury risk measured by urinary TIMP2*IGFBP7
Measured: Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours
Perioperative death
Death after surgery during the surgical hospital encounter
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Myocardial infarction
Myocardial infarction after surgery
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Stroke
Stroke after surgery
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New renal failure requiring renal replacement therapy
New renal failure requiring renal replacement therapy after surgery
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Re-exploration for bleeding
Need for surgical re-exploration to control hemorrhage
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative sepsis
Post-operative sepsis determined by positive blood culture
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset atrial fibrillation
Post-operative new onset atrial fibrillation
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative blood loss
Post-operative blood loss determined by total surgical drain output
Measured: From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours
Duration of mechanical ventilation
Duration of mechanical ventilation after surgery
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative delirium
Post-operative delirium determined by the Confusion Assessment Method for the Intensive Care Unit score
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative hospital length of stay
Duration of hospital stay after surgery
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New requirement for mechanical circulatory support
Post-operative initiation of mechanical circulatory support
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Intra-operative red blood cell transfusion
Intra-operative red blood cell transfusion in units
Measured: During the intra-operative time period, up to 12 hours
Post-operative red blood cell transfusion
Post-operative red blood cell transfusion in units
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative platelet transfusion
Post-operative platelet transfusion in units
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative plasma transfusion
Post-operative plasma transfusion in units
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative cryoprecipitate transfusion
Post-operative cryoprecipitate transfusion in units
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Intra-operative platelet transfusion
Intra-operative platelet transfusion in units
Measured: During the intra-operative time period, up to 12 hours
Intra-operative plasma transfusion
Intra-operative plasma transfusion in units
Measured: During the intra-operative time period, up to 12 hours
Intra-operative cryoprecipitate transfusion
Intra-operative cryoprecipitate transfusion in units
Measured: During the intra-operative time period, up to 12 hours
Glycocalyx thickness
Glycocalyx thickness determined by sublingual microcirculation microscopy
Measured: Start of the intra-operative period to 24 hours after intensive care unit admission
Microvascular circulatory function
Microvascular circulatory function determined by sublingual microcirculation microscopy
Measured: Start of the intra-operative period to 24 hours after intensive care unit admission
New onset of acute lung injury
Diagnosis of acute lung injury by PaO2 to FiO2 ratio
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset of left ventricular diastolic dysfunction
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.
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset of left ventricular systolic dysfunction
New onset of left ventricular systolic dysfunction determined by a LV ejection fraction <50%
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset of right ventricular systolic dysfunction
New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm
Measured: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start5 Jul 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nathan J Clendenen, MD, MS, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344573
- Sponsor's protocol ID
- 20-2465
- Other IDs
- K23HL151882
- Status last verified
- Nov 2024
- First submitted
- 1 Mar 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05344573
- Acronym / sponsor ID
- 20-2465
- Conditions
- Endothelial Dysfunction, Acute Kidney Injury
- Keywords
- Endothelial function, Acute Kidney Injury, Cardiopulmonary bypass, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 25 Apr 2022 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pulsatile cardiopulmonary bypass | – | –Subjects who undergo cardiac surgery with non-pulsatile cardiopulmonary bypass |
| Pulsatile cardiopulmonary bypass | – | –Subjects who undergo cardiac surgery with pulsatile cardiopulmonary bypass |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 50 to 70 years scheduled for elective cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (3 listed)
- Age 50 to 70
- Able to provide informed consent
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
29 secondary outcomes
Acute kidney injury
Time frame: From intensive care unit admission after surgery to intensive care unit discharge, up to 7 days
Renal blood flow velocity
Time frame: Intra-operative time point: after cardiopulmonary bypass, up to 12 hours
Acute kidney injury risk
Time frame: Measured 4 hours after the end of cardiopulmonary bypass, up to 12 hours
Perioperative death
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Myocardial infarction
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Stroke
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New renal failure requiring renal replacement therapy
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Re-exploration for bleeding
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative sepsis
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset atrial fibrillation
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative blood loss
Time frame: From intensive care unit admission to 24 hours after intensive care unit admission, up to 24 hours
Duration of mechanical ventilation
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative delirium
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative hospital length of stay
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New requirement for mechanical circulatory support
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Intra-operative red blood cell transfusion
Time frame: During the intra-operative time period, up to 12 hours
Post-operative red blood cell transfusion
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative platelet transfusion
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative plasma transfusion
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Post-operative cryoprecipitate transfusion
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Intra-operative platelet transfusion
Time frame: During the intra-operative time period, up to 12 hours
Intra-operative plasma transfusion
Time frame: During the intra-operative time period, up to 12 hours
Intra-operative cryoprecipitate transfusion
Time frame: During the intra-operative time period, up to 12 hours
Glycocalyx thickness
Time frame: Start of the intra-operative period to 24 hours after intensive care unit admission
Microvascular circulatory function
Time frame: Start of the intra-operative period to 24 hours after intensive care unit admission
New onset of acute lung injury
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
New onset of left ventricular diastolic dysfunction
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
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 right ventricular systolic dysfunction
Time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- 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.
Nathan J Clendenen, MD, MS principal investigator
University of Colorado Denver | Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction and Acute Kidney Injury, run by University of Colorado, Denver at 1 site in United States.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan J Clendenen, MD, MS ((303) 724-5375, nathan.clendenen@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: From intensive care unit admission after surgery to hospital discharge, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.