Inhaled nitrogen will be administered via the cardiopulmonary bypass (CPB) machine and after CPB via the inspiratory limb of the anesthetic or ventilator circuit, and thereafter via the mechanical ventilator in the Intensive Care Unit (ICU). Once patients are extubated they will breathe test gas via a facemask or nasal cannula. Test gas administration will commence at the onset of CPB and last for 24 hours.

Inhaled nitric oxide (iNO) will be administered via the CPB machine and after CPB via the inspiratory limb of the anesthetic or ventilator circuit, and thereafter via the mechanical ventilator in the ICU. Once patients are extubated they will breathe test gas via a facemask or nasal cannula. Test gas administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, iNO will be weaned and discontinued while carefully monitoring hemodynamics for a period of 2-4 hours.

Acute Kidney Injury

Inhaled nitric oxide will be administered in a final concentration of 80 ppm. The treatment will begin at the onset of the cardiopulmonary bypass until to 24h after Intensive Care Unit (ICU) admission, including 2-4 hours of weaning from nitric oxide and careful hemodynamics monitoring.

Nitric Oxide

This is the placebo group. Nitrogen will be added instead of nitric oxide.

Placebo

This is the clinical trial that we previously performed in collaboration with Xijing Hospital.

The first preliminary data analysis of the NCT01802619 has been presented at the section "Late Breaking Trial" of the American Heart Association in Orlando,Florida,November 2015.

Massachusetts General Hospital

Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.

Prevention of Acute Kidney Injury by Nitric Oxide in Prolonged Cardiopulmonary Bypass. A Double Blind Controlled Randomized Trial in Cardiac Surgical Patients With Endothelial Dysfunction.

Incidence of Acute Kidney injury according to KDIGO criteria.

Difference in AKI severity between the two groups using following KDIGO stages.

To study the incidence of acute renal failure requiring RRT

Difference between groups of MAKE at 6 weeks after surgery. MAKE is a composite outcome of death, new dialysis and worsened renal function (defined as a 25% or greater decline in eGFR compared to the baseline).

Assessment of organ dysfunction through the evaluation of SOFA score

Difference between groups of prolonged cardiovascular support defined as need for vasopressors, inotropic agents, balloon pump, or ventricular-assist device for more than 48 hours after cardiac surgery.

Difference between groups of maximum daily VIS and duration of vasopressors and or inotropic agents support. VIS is calculated as Dopamine dose (mcg/kg/min) + Dobutamine dose (mcg/kg/min) + 100 x Epinephrine dose (mcg/kg/min) + 10 x Milrinone dose (mcg/kg/min) + 10,000 x Vasopressin dose (units/kg/min) + 100 x Norepinephrine dose (mcg/kg/min) + 10 x Phenilephrine dose (mcg/kg/min).

Difference of duration of mechanical ventilation

Difference between groups of ICU-LOS defined as number of days spent in an ICU bed.

Difference between groups of hospital LOS defined as number of days spent in a hospital bed.

Renal biomarkers to evaluate renal tubular injury.

Incidence and severity of AKI related to presence of CKD at baseline, duration of CPB, duration of aortic cross clamp, levels of free Hb, levels of NO consumption, pulmonary pressure at baseline, cardiovascular risks associated with endothelial dysfunction, scheduled procedure and EuroSCORE II.

Difference between groups of Incidence of Delirium will be assessed daily in the first 7 days after surgery by using the confusion assessment method for intensive care unit (CAM-ICU).

Analysis of the quality of life up to 1 year after surgery by the Activity of Daily Living evaluation (by Katz Index) and PROMIS global health.

Evaluation of the overall intrahospital mortality and at 28 6 weeks 90 days and 1 year after surgery

Blood methemoglobin levels will be measured to evaluate the oxidation of oxyhemoglobin in the two groups until 48h after surgery.

Difference between groups of incidence of non fatal stroke will be assessed by at 6 weeks after cardiac surgery.

Incidence of Perioperative and non-perioperative nonfatal myocardial infarction as defined by the third universal definition of MI released in 2012 by the ESC/ACCF/AHA/WHF.

Incidence of postoperative bleeding calculated as the sum of blood loss through thoracic drains from the moment of closure of the chest over a period of 24 hours.

Differences between the two groups of transfusions with plasma and stored or autologous red blood cells (RBCs) recovered using intraoperative cell salvage devices.

Post-operative infections (e.g., pneumonia, wound infection, endocarditis, central line infection, urinary tract infection, sepsis).

Cardiac arrhythmias and other non-cardiac post-operative complications (e.g., hepatobiliary disorders, pneumothorax, pleural effusion, vascular disorders).

Lorenzo Berra, MD

Lorenzo Berra, MD, Assistant Professor, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School

Ichinose, Fumito, M.D., Ph.D., Massachusetts General Hospital

Kenneth, Shelton, M.D., Massachusetts General Hospital

Kacmarek, Robert M., Ph.D., Massachusetts General Hospital

Sundt, Thoralf M., M.D., Massachusetts General Hospital

Villavicencio-Theoduloz, Mauricio A., M.D., Massachusetts General Hospital

Thompson, Boyd Taylor, M.D., Massachusetts General Hospital

Bonventre, Joseph V., M.D., Brigham Women Hospital

Shann, Kenneth G., Massachusetts General Hospital

Zapol, Warren M., M.D.

Marrazzo, Francesco, M.D., Massachusetts General Hospital

Spina, Stefano, M.D., Massachusetts General Hospital

Zadek, Francesco, M.D., Massachusetts General Hospital

Rezoagli, Emanuele, M.D., Massachusetts General Hospital

National Heart, Lung, and Blood Institute (NHLBI)

After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to spironolactone. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.

After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to placebo. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.

End Stage Renal Failure on Dialysis

Spironolactone

Hôpital Erasme- Bruxelles

CH Ardeche Nord

CHU Amiens

CH Avignon

CHU Besançon

CHU Bordeaux

CH Boulogne Sur Mer

CHRU Brest

CHU Caen

CH Cahors

CH Chambéry

CHPC Cherbourg

AURAL Colmar

Hopitaux Civils de Colmar

APHP Henri Mondor

CHU Dijon Hôpital du Bocage

AGDUC Grenoble

AURAL Haguenau

CH Haguenau

La Roche Sur Yon

Polyclinique de Lagny

Clinique Lille

CHU Lille

ALURAD Limoges

CHU Limoges

CHG Lisieux

CHU de Lyon

AURAL La Croix Rousse

CH St Joseph-St Luc

AURAL Lyon

Clinique Bouchard

Clinique Marseille

Adpc Marseille

APHM Marseille

Clinique du pont Allant

Association de Metz

ALTIR Metz

CHR Metz-Thionville

AURAL Mulhouse

CH Mulhouse

CHU Nancy

CHU Nantes

CHU Nice

Clinique St Georges

AP-HP La Salpêtrière

AURA Paris 14ème

AURA Paris Plaisance

Hôpital Tenon

AP-HP Necker

Institut Mutualiste Montsouris

CHU Lyon Sud

CHU de Reims

ARPDD Reims

AUB Rennes

CHU Rennes

ECHO Confluent

Centre de Perharidy

CH Roubaix

CHU de la Réunion Hôpital Félix Guyon

CH Mémorial Saint Lô

Aub Saint Malo

Ch Saint Malo

CHG St Brieuc

CH St Maurice

AURAL St Anne (AURAL Strasbourg)

CHU Strasbourg

AURAL Strasbourg

CHU Toulouse

CHU Tours

CH Troyes

CH Valenciennes

ALTIR Nancy

Hôpitaux Privés de Metz- Hôpital Robert Schuman

CH Verdun

CH Vichy

CH Princesse Grace

ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial

ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST), Phase III b

University Hospital, Brest

Central Hospital, Nancy, France

Institut National de la Santé Et de la Recherche Médicale, France

The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:
Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.

H.E.L.P. Secura

Not all sites collected this information.

Gender

Region of Enrollment

The Categories listed in the table are the Adverse Events (or similar) that resulted in death.

Occurence of Death

Adverse Events reported for Cardiovascular disease not directly related to therapy.

Occurrence of Cardiovascular Events and Interventions

Serious Unexpected Adverse Events

This is equatable to the incidence of Cardiovascular AEs.

Frequency and Severity of CHD Symptoms (Angina)

All patients received the same Treatment Arm for this study. Treatments were conducted up to 3 times per week; treatment sessions typ. 2 hours in length.
H.E.L.P. is a device composed of multiple modules and associated disposables to selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient.
Flush system with normal saline;
Filter whole blood through 0.2 micron plasma filter for continuous plasma removal;
Mix plasma with equal volume of acetate buffer containing heparin;
Precipitate LDL as a complex with heparin;
Remove LDL-heparin precipitate by continuous circulation through a filter;
Remove heparin with use of a heparin adsorber;
Bicarbonate dialysis and ultrafiltration to produce LDL-free plasma without excess heparin;
Re-mix LDL-free plasma with blood from plasma filter; return reconstituted blood to patient.

resin/infarction

Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.

ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial

Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy

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