Elective Cardiac Surgery Clinical Trial
Official title:
Non Randomised, Prospective, Single Center Clinical Study to Evaluate the Safety and Procedural Feasibility of an Innovative Flow Assist Device, Pleioflow-RF.
The "Pleiades" study is a non randomised, prospective, single center clinical trial that aims to evaluate the safety and the procedural feasibility of an innovative flow assist device (Pleioflow-RF) in adult patients undergoing elective cardiac surgery.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Age = 18 and = 85, men and women 2. Elective coronary artery bypass grafting surgery and/or heart valve surgery with planned CPB. 3. Written informed consent provided 4. Haemoglobulin (Hb) = 11 g/dl in women and = 12 g/dl for men 5. Ejection fraction = 30% 6. Score= 3 according to the Cleveland Clinic Foundation risk factor scale for AKI and / or Chronic Kidney Disease (CKD) with preoperative glomerular filtration rate, estimated glomerular filtration rate, eGFR =50 ml / min / 1.7, 3 m2) as estimated by the equation of four Modified Diet and Renal Disease variables (MDRD type) Exclusion Criteria: 1. emergency surgery 2. severe sepsis or rhabdomyolysis 3. severe preoperative renal insufficiency requiring renal replacement therapy (RRT) or even once RRT 4. receiving within the last 10 days nephrotoxic medications, such as radiocontrast material (> 100 ml), amphotericin B, aminoglycosides, NSAID, or trimethoprim-sulfamethoxazole with at least moderate renal impairment (eGFR =45) 5. Any severe coagulopathy 6. Participation in another trial 7. Any surgical or medical condition which according to investigator's opinion could create problem in the assessment of safety and /or efficacy of the device 8. Severe comorbidity with life expectancy < 6 months 9. History of poor compliance with previous treatment and incapability of giving informed consent 10. Pregnant or breastfeeding women. Pregnancy, confirmed by a positive laboratory test for Human Chorionic Gonadotropin, is considered from the time after conception until the end of the pregnancy. 11. Peripheral artery disease making insertion of IABP unfeasible 12. Preoperative intra-aortic balloon pump (IABP) 13. Preoperative other device in the same anatomical area (which could possibly create dysfunction of any of the other two devices) |
Country | Name | City | State |
---|---|---|---|
Greece | Onassis Cardiac Center | Athens |
Lead Sponsor | Collaborator |
---|---|
Pleioflow |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of the Pleioflow-RF device | Feasibility: Initiation and maintenance the Mean of the maxima (maximum values) of pulsatile pressure =65mmHg during cardiopulmonary bypass (CPB) | Through end of Device removal procedure | |
Primary | Safety of the Pleioflow-RF device | Safety: Major Device-Related Adverse Events | Through end of Device removal procedure | |
Secondary | Duration of Intensive Care Unit/Intensive Therapy Unit (ICU/ITU) stay | 30 days | ||
Secondary | Duration of Hospital Stay | Up to 30 days postoperative | ||
Secondary | Acute Kidney injury (AKI) | Up to 7 days postopoerative | ||
Secondary | Need for renal replacement therapy | Up to 7 days | ||
Secondary | Intraoperative and Postoperative use of inotropes and vasopressors | Number of days and dose of inotropes and vasopressors | Up to 7 days postoperative | |
Secondary | 30-Day All-Cause Mortality | 30 days | ||
Secondary | Device- related adverse events | 30 days | ||
Secondary | Evaluation of clinical data. | Recording the haemodynamic data: arterial pressure above and below the device | Up to 4 hours | |
Secondary | Levels of biomarkers. | Recording the following biomarkers levels: Creatinine, Urea, electrolytes and Neutrophil gelatinase associated lipocalin (NGAL) | Up to 7 days | |
Secondary | Conversion of non- pulsatile to pulsatile flow and pressure during CPB | Up to 4 hours | ||
Secondary | Mean of Maximum pulsatile pressure values peripherally to the valve of the Pleiofow-RF device | Mean of Maximum pulsatile pressure values peripherally to the valve of the Pleiofow-RF device, greater than or equal to 80 mmHg (= 80 mm Hg), or increase of Mean of maxima (maximum values of pulsatile pressure), peripherally to the valve of the Pleiofow-RF device= 20 mmHg above the mean arterial pressure (MAP) of the non pulsatile flow of the extracorporeal circulation, the latter being recorded 2 minutes prior to the activation of the device | Up to 4 hours | |
Secondary | Incidence of Pleioflow-RF Device's dysfunction and failures | Through end of Device removal procedure | ||
Secondary | Measure of ease of device insertion delivery, deployment, positioning | Each assessment (insertion, delivery, deployment, and positioning) will be measured independently using the same unit according to the Procedure feasibility score scale as described in the Appendix 1 in the Protocol. A scale (Procedure feasibility score scale as described in the Appendix 1 in the Protocol) will be used to assess the aforementioned outcome. Minimum value is 1 and maximum value is 5, with higher scores stating a better outcome. | At time of device insertion | |
Secondary | Measure of ease of device removal | A scale (Procedure feasibility score scale as described in Appendix 1 in the Protocol) will be used to assess the aforementioned outcome. Minimum value is 1 and maximum value is 5, with higher scores stating a better outcome | Through end of Device removal procedure |
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