Optimizing Pulsatility During Cardiopulmonary Bypass

November 18, 2024 updated by: University of Colorado, Denver

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Contact:
        • Principal Investigator:
          • Nathan J Clendenen, MD MS

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients aged 50 to 70 years scheduled for elective cardiac surgery with cardiopulmonary bypass

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From intensive care unit admission after surgery to hospital discharge, up to 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Renal blood flow velocity measured by pulse wave doppler
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
Acute kidney injury risk measured by urinary TIMP2*IGFBP7
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
Death after surgery during the surgical hospital encounter
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
Myocardial infarction after surgery
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
Stroke after surgery
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
New renal failure requiring renal replacement therapy after surgery
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
Need for surgical re-exploration to control hemorrhage
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
Post-operative sepsis determined by positive blood culture
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 new onset atrial fibrillation
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
Post-operative blood loss determined by total surgical drain output
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
Duration of mechanical ventilation after surgery
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 delirium determined by the Confusion Assessment Method for the Intensive Care Unit score
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
Duration of hospital stay after surgery
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
Post-operative initiation of mechanical circulatory support
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
Intra-operative red blood cell transfusion in units
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 red blood cell transfusion in units
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 platelet transfusion in units
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 plasma transfusion in units
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
Post-operative cryoprecipitate transfusion in units
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 platelet transfusion in units
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 plasma transfusion in units
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
Intra-operative cryoprecipitate transfusion in units
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
Glycocalyx thickness determined by sublingual microcirculation microscopy
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
Microvascular circulatory function determined by sublingual microcirculation microscopy
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
Diagnosis of acute lung injury by PaO2 to FiO2 ratio
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
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.
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 left ventricular systolic dysfunction determined by a LV ejection fraction <50%
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
New onset of right ventricular systolic dysfunction determined by a tricuspid annular plane systolic excursion less than 16 mm
From intensive care unit admission after surgery to hospital discharge, up to 30 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathan J Clendenen, MD, MS, University of Colorado Denver | Anschutz

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-2465
  • K23HL151882 (U.S. NIH Grant/Contract)

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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