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| ID | Type | Description | Link |
|---|---|---|---|
| 81000232 | Other Grant/Funding Number | National Natural Science Foundation of China |
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Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) during and after the surgical procedure on CPB may protect against endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging.
Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) during and after the surgical procedure on CPB may protect against endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging. There are three possible beneficial mechanisms of delivering NO:
NO depletion during hemolysis and its sequelae. The release of plasma free Hb (with Fe2+ iron) by hemolysis avidly scavenges nitric oxide (NO) by the dioxygenation reaction. Elevated plasma ferrous Hb levels can induce a "NO deficiency" state. Reduced vascular nitric oxide levels can contribute to vasoconstriction, inflammation, and thrombosis, potentially contributing to systemic endothelial dysfunction after cardiac surgery with CPB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inhaled nitrogen | Placebo Comparator | Using an Inovent (Ikaria Inc, N.J., USA) or volumetrically-calibrated flowmeters, pure nitrogen (placebo) is mixed with pure O2 or air. During CPB the gas mixture is delivered through the extracorporeal oxygenator, after CPB the NO is delivered through the inspiratory limb of the anesthetic or ventilator circuit. |
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| inhaled nitric oxide | Experimental | Using an Inovent (Ikaria Inc, N.J., USA) or volumetrically-calibrated flowmeters, 800 ppm NO gas is mixed with pure O2 or air to obtain a final concentration of 80 ppm NO. During CPB the gas mixture is delivered through the extracorporeal oxygenator, after CPB the gas is delivered through the inspiratory limb of the anesthetic or ventilator circuit. NO, NO2 and O2 and methemoglobin levels are monitored by an unblinded observer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled nitric oxide | Other | Nitric oxide administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, inhaled NO will be weaned and discontinued while carefully monitoring hemodynamics for a period of 2-4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| acute kidney injury | acute kidney injury was defined by the KDIGO criteria | an increase of serum creatinine by 50% within 7 days after surgery, or an increase of serum creatinine by 0.3 mg/dl within 2 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic kidney disease | defined as eGFR<60 mL/min/1.73m2 | at 30 days, 90 days, and 1 year following ICU admission |
| Loss of 25% of eGFR compared to baseline | Loss of 25% of eGFR compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital stay | It is the length of hospital stay | Normally within 30 days, when patients was discharged from ICU |
| ICU-stay | It is the length of stay in ICU |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| lize Xiong, M.D.,Ph.D. | Xijing Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33481401 | Derived | Hu J, Rezoagli E, Zadek F, Bittner EA, Lei C, Berra L. Free Hemoglobin Ratio as a Novel Biomarker of Acute Kidney Injury After On-Pump Cardiac Surgery: Secondary Analysis of a Randomized Controlled Trial. Anesth Analg. 2021 Jun 1;132(6):1548-1558. doi: 10.1213/ANE.0000000000005381. | |
| 29932345 | Derived | Lei C, Berra L, Rezoagli E, Yu B, Dong H, Yu S, Hou L, Chen M, Chen W, Wang H, Zheng Q, Shen J, Jin Z, Chen T, Zhao R, Christie E, Sabbisetti VS, Nordio F, Bonventre JV, Xiong L, Zapol WM. Nitric Oxide Decreases Acute Kidney Injury and Stage 3 Chronic Kidney Disease after Cardiac Surgery. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1279-1287. doi: 10.1164/rccm.201710-2150OC. |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| inhaled Nitrogen | Other | Standard gas including nitrogen (the vehicle of the Nitric oxide) administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, inhaled gases will be weaned and discontinued while carefully monitoring hemodynamics for a period of 2-4 hours. |
|
| at 30 days, 90 days, and 1 year following ICU admission |
| Major adverse kidney events (MAKE) | a composite outcome of loss of 25% of eGFR from baseline, end stage renal disease requiring a continuous renal replacement therapy and mortality. | at 30 days, 90 days, and 1 year following ICU admission |
| Renal Replacement Therapy | the incidence of need for Renal Replacement Therapy | at 30 days, 90 days, and 1 year following ICU admission |
| Incidence of nonfatal stroke and nonfatal myocardial infarction. | Nonfatal stroke will be assessed by the NIH Stroke Scale at baseline before surgery and at 28 days, 60 days, 90 days and 1 year after surgery. Nonfatal myocardial infarction is defined by the third universal definition of MI released in 2012 by the ESC/ACCF/AHA/WHF. | at 30 days, 90 days, and 1 year following ICU admission |
| Quality of life | The quality of life will be evaluated by the Katz Index of In dependence in Activities of Daily living | at 30 days, 90 days, and 1 year following ICU admission |
| overall mortality | all cause mortality | at 30 days, 90 days, and 1 year following ICU admission |
| Normally within 30 days, when patients was discharged from ICU |
| Incidence of prolonged ventilation | Prolonged ventilation is defined as patients remaining on the ventilator for more than 48 hours | During hospital stay, normally within 30 days |