Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

Surgery Clinical Trial

Official title:

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06349577
• Other study ID #: 23-0921
• Secondary ID: 5K23HL151882
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2028

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Nathan J Clendenen, MD,MS
• Phone: 3037245000
• Email: nathan.clendenen[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 bypass.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: October 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Able to provide informed consent

• Scheduled for elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

• 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

• Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)

• Requiring mechanical circulatory support

• Requiring vasoactive medications

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hemolysis
• Surgery
• Thrombocytopenia
• Wounds and Injuries

Intervention

Other:
• Non-pulsatile blood flow
Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
• Pulsatile blood flow
Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Khwaja 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. — View Citation

Tan 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Myocardial infarction	Myocardial infarction by clinical diagnosis	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Stroke	Stroke by clinical diagnosis	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Renal failure requiring renal replacement therapy	New diagnosis of renal failure requiring renal replacement therapy	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Re-exploration for bleeding	Surgical re-exploration for bleeding	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Sepsis	Diagnosed by positive blood culture	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	New onset atrial fibrillation	Clinical diagnosis of new onset atrial fibrillation	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Duration of mechanical ventilation	Duration of mechanical ventilation	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Post-operative delirium	Post-operative determined by the Confusion Assessment Method for the Intensive Care Unit	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Post-operative hospital length of stay	Post-operative hospital length of stay	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	New requirement for mechanical circulatory support	New requirement for mechanical circulatory support	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Intra-operative red blood cell transfusion in units	Intra-operative red blood cell transfusion in units	During the intra-operative time period, up to 12 hours
Other	Post-operative red blood cell transfusion in units	Post-operative red blood cell transfusion in units	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Post-operative platelet transfusion in units	Post-operative platelet transfusion in units	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Post-operative plasma transfusion in units	Post-operative plasma transfusion in units	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Post-operative cryoprecipitate transfusion in units	Post-operative cryoprecipitate transfusion in units	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	Intra-operative platelet transfusion in units	Intra-operative platelet transfusion in units	During the intra-operative time period, up to 12 hours
Other	Intra-operative plasma transfusion in units	Intra-operative plasma transfusion in units	During the intra-operative time period, up to 12 hours
Other	Intra-operative cryoprecipitate transfusion in units	Intra-operative cryoprecipitate transfusion in units	During the intra-operative time period, up to 12 hours
Other	New onset of acute lung injury	Diagnosis of acute lung injury by PaO2 to FiO2 ratio = 300	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Other	New onset of left ventricular systolic dysfunction	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
Other	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	From intensive care unit admission after surgery to hospital discharge, up to 30 days
Primary	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	From intensive care unit admission after surgery up to 7 days
Secondary	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	On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival
Secondary	Red blood cell units transfused	Number of allogenic red blood cell units transfused after cardiopulmonary bypass	After cardiopulmonary bypass up to 24 hours after intensive care unit arrival
Secondary	Platelet nadir	Lowest platelet count after cardiopulmonary bypass	On admission to the intensive care unit after surgery up to 7 days
Secondary	Discontinuation rate of cardiopulmonary bypass mode	Discontinuation rate of pulsatile or non-pulsatile cardiopulmonary bypass mode	During cardiopulmonary bypass
Secondary	30-day mortality	All cause mortality	From intensive care unit admission after surgery to hospital discharge, up to 30 days