Acute Kidney InjuryNCT06349577
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury
A study testing Non-pulsatile blood flow and Pulsatile blood flow in people with Acute Kidney Injury and Hemolysis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Hemolysis, Thrombocytopenia
- What is being tested?
- Non-pulsatile blood flow and Pulsatile blood flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to Oct 2028
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- Emergency procedures
- Scheduled for heart or lung transplantation
- Scheduled for ventricular assist device implantation
- Use of the Medtronic Elongated Once-Piece Arterial Cannula
- Diagnosed with sepsis
- Diagnosed with delirium
Show all 9Show fewer
- Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
- Requiring mechanical circulatory support
- Requiring vasoactive medications
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, nathan.clendenen@cuanschutz.edu
Nathan J Clendenen, MD MS
About this study
Official title: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial
The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.
Read the detailed description
Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass.
Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.
Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.
- Conditions
- Acute Kidney Injury, Hemolysis, Thrombocytopenia, Surgery
- Being tested
- Non-pulsatile blood flow, Pulsatile blood flow
- Medical subject headings
- Acute Kidney Injury, Hemolysis, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pulsatile blood flowOther
Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
Pulsatile blood flowOther
Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Non-pulsatile blood flow | Active comparator | Non-pulsatile blood flow during cardiopulmonary bypass Receives: Other: Non-pulsatile blood flow |
| Pulsatile blood flow | Active comparator | Pulsatile blood flow during cardiopulmonary bypass Receives: Other: Pulsatile blood flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Stage 1 (mild), 2 (moderate), or 3 (severe) acute kidney injury according to the Kidney Disease Improving Global Outcomes creatinine criteria (stage 1 = 1.5 to 1.9 times baseline or greater than or equal to 0.3 milligrams per deciliter increase in serum creatinine, stage 2 = 2.0 to 2.9 times baseline in serum creatinine, stage 3 = 3.0 times baseline or increase in serum creatinine greater than or equal to 4.0 milligrams per deciliter or initiation of renal replacement therapy
Measured: From intensive care unit admission after surgery up to 7 days
Secondary outcomes (5)
Acute kidney injury risk score
Demirjian Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery in percent predicted risk
Measured: On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival
Red blood cell units transfused
Number of allogenic red blood cell units transfused after cardiopulmonary bypass
Measured: After cardiopulmonary bypass up to 24 hours after intensive care unit arrival
Platelet nadir
Lowest platelet count after cardiopulmonary bypass
Measured: On admission to the intensive care unit after surgery up to 7 days
Discontinuation rate of cardiopulmonary bypass mode
Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode
Measured: During cardiopulmonary bypass
30-day mortality
All cause mortality
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 posted5 Apr 2024
- Study start19 May 2025
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349577
- Sponsor's protocol ID
- 23-0921
- Other IDs
- 5K23HL151882
- Status last verified
- May 2025
- First submitted
- 19 Mar 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demirjian S, Bashour CA, Shaw A, Schold JD, Simon J, Anthony D, Soltesz E, Gadegbeku CA. Predictive Accuracy of a Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery. JAMA. 2022 Mar 8;327(10):956-964. doi: 10.1001/jama.2022.1751.
PubMed 35258532Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
PubMed 22890468Tan A, Newey C, Falter F. Pulsatile Perfusion during Cardiopulmonary Bypass: A Literature Review. J Extra Corpor Technol. 2022 Mar;54(1):50-60. doi: 10.1182/ject-50-60.
PubMed 36380831
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. 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: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06349577
- Acronym / sponsor ID
- 23-0921
- Conditions
- Acute Kidney Injury, Hemolysis, Thrombocytopenia, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 May 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Apr 2024 (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.
The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.
Detailed description
Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass.
Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.
Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pulsatile blood flow | Active comparator | Other: Non-pulsatile blood flowNon-pulsatile blood flow during cardiopulmonary bypass |
| Pulsatile blood flow | Active comparator | Other: Pulsatile blood flowPulsatile blood flow during cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to provide informed consent
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (9 listed)
- Emergency procedures
- Scheduled for heart or lung transplantation
- Scheduled for ventricular assist device implantation
- Use of the Medtronic Elongated Once-Piece Arterial Cannula
- Diagnosed with sepsis
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 |
|---|---|---|
| Non-pulsatile blood flowNon-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass | Other | Non-pulsatile blood flow |
| Pulsatile blood flowPulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass | Other | Pulsatile blood flow |
Primary outcome
Acute kidney injury
Time frame: From intensive care unit admission after surgery up to 7 days
Stage 1 (mild), 2 (moderate), or 3 (severe) acute kidney injury according to the Kidney Disease Improving Global Outcomes creatinine criteria (stage 1 = 1.5 to 1.9 times baseline or greater than or equal to 0.3 milligrams per deciliter increase in serum creatinine, stage 2 = 2.0 to 2.9 times baseline in serum creatinine, stage 3 = 3.0 times baseline or increase in serum creatinine greater than or equal to 4.0 milligrams per deciliter or initiation of renal replacement therapy
5 secondary outcomes
Acute kidney injury risk score
Time frame: On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival
Red blood cell units transfused
Time frame: After cardiopulmonary bypass up to 24 hours after intensive care unit arrival
Platelet nadir
Time frame: On admission to the intensive care unit after surgery up to 7 days
Discontinuation rate of cardiopulmonary bypass mode
Time frame: During cardiopulmonary bypass
30-day mortality
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 May 2025.
- Background: PubMed 35258532Demirjian S, Bashour CA, Shaw A, Schold JD, Simon J, Anthony D, Soltesz E, Gadegbeku CA. Predictive Accuracy of a Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery. JAMA. 2022 Mar 8;327(10):956-964. doi: 10.1001/jama.2022.1751.
- Background: PubMed 22890468Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
- Background: PubMed 36380831Tan A, Newey C, Falter F. Pulsatile Perfusion during Cardiopulmonary Bypass: A Literature Review. J Extra Corpor Technol. 2022 Mar;54(1):50-60. doi: 10.1182/ject-50-60.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-pulsatile blood flow and Pulsatile blood flow in people with Acute Kidney Injury and Hemolysis, 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 2 inclusion and 9 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 May 2025. 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 (3037245000, nathan.clendenen@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: From intensive care unit admission after surgery up to 7 days). 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 NCT06349577, which also lists 3 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 21 May 2025.