A Multicenter, Randomized, Controlled Phase IIb Trial of Avoidance of Hyperoxemia during Cardiopulmonary Bypass

2016 ◽  
Vol 125 (3) ◽  
pp. 465-473 ◽  
Author(s):  
Shay P. McGuinness ◽  
Rachael L. Parke ◽  
Kate Drummond ◽  
Tim Willcox ◽  
Michael Bailey ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Cardiac Surgery ◽  
Intensive Care ◽  
Cardiopulmonary Bypass ◽  
Length Of Stay ◽  
Usual Care ◽  
Organ Damage ◽  
Controlled Study ◽  
Multiorgan Dysfunction ◽  
Randomized Controlled

Abstract Background Cardiac surgery utilizing cardiopulmonary bypass (CPB) is one of the most common forms of major surgery. Cardiac surgery–associated multiorgan dysfunction (CSA-MOD) is well recognized and includes acute kidney injury (AKI), hepatic impairment, myocardial damage, and postoperative neurologic deficit. Pathophysiology of CSA-MOD involves numerous injurious pathways linked to the use of CPB including oxidative stress and formation of reactive iron species. During cardiac surgery with CPB, arterial return blood is oxygenated to supranormal levels. This study aimed to determine whether the avoidance of arterial hyperoxemia decreased oxidative stress and reduced the severity of the multiorgan dysfunction in patients undergoing cardiac surgery utilizing CPB. Methods The study was a multicenter, open-label, parallel-group, randomized controlled study of the avoidance of arterial hyperoxemia versus usual care in patients undergoing cardiac surgery involving CPB. Primary outcome was the incidence and severity of AKI. Secondary outcomes included serum biomarkers for CSA-MOD, duration of mechanical ventilation, and length of intensive care and hospital stay. Results A total of 298 patients were randomized and analyzed at two hospitals in New Zealand and Australia. Mean Pao2 was significantly different between groups during CPB. There was no difference in the development of AKI (intervention arm 72.0% vs. usual care 66.2%; difference, −5.8% [95% CI, −16.1 to 4.7%]; P = 0.28), other markers of organ damage, or intensive care unit and hospital length of stay. Conclusions Avoiding modest hyperoxemia during CPB failed to demonstrate any difference in AKI, markers of organ damage, or length of stay.

Effect of Albumin Addition to Cardiopulmonary Bypass Prime on Outcomes in Children Undergoing Open-Heart Surgery (EACPO Study)—A Randomized Controlled Trial

2020 ◽  
pp. 215013512095908
Author(s):  
Abdul Rauf ◽  
Reena K. Joshi ◽  
Neeraj Aggarwal ◽  
Mridul Agarwal ◽  
Manendra Kumar ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Cardiopulmonary Bypass ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Controlled Study ◽  
Risk Category ◽  
Open Heart ◽  
Oncotic Pressure ◽  
Randomized Controlled

Background: There is a paucity of literature regarding the association of high oncotic priming solutions for pediatric cardiopulmonary bypass (CPB) and outcomes, and no consensus exists regarding the composition of optimal CPB priming solution. This study aimed to examine the impact of high oncotic pressure priming by the addition of 20% human albumin on outcomes. Methods: Double-blinded, randomized controlled study was done in the pediatric cardiac intensive care unit of a tertiary care hospital. Consecutive children with congenital heart diseases admitted for open-heart surgery were randomized into two groups, where the study group received an additional 20% albumin to conventional blood prime before CPB initiation. Results: We enrolled 39 children in the high oncotic prime (added albumin) group and 37 children in the conventional prime group. In the first 24-hour postoperative period, children in the albumin group had significantly lower occurrence of hypotension (28.2% vs 54%, P = .02), requirement of fluid boluses (25.6% vs 54%, P = .006), and lactate clearance time (6 vs 9 hours, P < .001). Albumin group also had significantly higher platelet count (×103/µL) at 24 hours (112 vs 91, P = .02). There was no significant difference in intra-CPB hemodynamic parameters and incidence of acute kidney injury. In subgroup analysis based on risk category, significantly decreased intensive care unit stay (4 vs 5 days, P = .04) and hospital stay (5 vs 7 days, P = .002) were found in the albumin group in low-risk category. Conclusion: High oncotic pressure CPB prime using albumin addition might be beneficial over conventional blood prime, and our study does provide a rationale for further studies.

Abstract 14827: Nitric Oxide During Cardiopulmonary Bypass Improves Clinical Outcome: A Blinded, Randomized Controlled Trial

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Christopher S James ◽  
Stephen Horton ◽  
Christian Brizard ◽  
Charlotte Molesworth ◽  
Johnny Millar ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Length Of Stay ◽  
Gas Flow ◽  
Controlled Trial ◽  
Age Group ◽  
Randomized Controlled ◽  
Icu Length Of Stay

Background: Children requiring cardiac surgery with cardiopulmonary bypass (CPB) frequently develop Low Cardiac Output Syndrome (LCOS), particularly when very young, A pilot study of 16 children by Checchia et al. (2013) showed that the delivery of nitric oxide (NO) to the CPB circuit shortened duration of mechanical ventilation and ICU stay. We hypothesized that administering NO to oxygenator gas flow during CPB would decrease the incidence of LCOS and effect subsequent clinical outcomes. Methods: We conducted a prospective, blinded, randomized controlled trial in children with congenital heart disease having surgery with CPB. Randomization was stratified by age and ‘blocked’ at six in each group. Children received oxygen alone or 20 ppm gaseous NO and oxygen to the CPB gas administration line. Only the study perfusionist was aware of the allocation and all equipment and devices were otherwise identical in each group; in particular the cardiac surgeon and anesthetist remained blinded to patient allocation. Results: 198 children were enrolled following written consent. There were no differences in patient characteristics, diagnoses or surgeries between groups. 101 children received NO and had a significant reduction in LCOS (14% vs 31%, p=0.004), use of ECMO (1% vs 8%, p=0.014) and a non-significant reduction in ICU length of stay (48hrs vs 72hrs, p=0.111), compared to the 97 children who did not receive NO. The reduction in LCOS was most pronounced in children less than 6 weeks of age (20% vs 52%, p=0.012) and in those aged 6 weeks to 2 years (6% vs 24%, p=0.026), who also had significantly reduced ICU length of stay (43hrs vs 84hrs, p=0.031). LCOS occurred equally between groups in children greater than 2 years of age (17% vs 21%, p=0.678). There was no difference in the amount of post-operative bleeding in any age group. Children greater than 2 years of age who received NO required fewer blood transfusions (8.3% vs 24.1%, p=0.096). Conclusions: Delivery of NO to the CPB circuit for children undergoing cardiac surgery significantly reduces the incidence of LCOS, use of ECMO and ICU length of stay by varying degrees, according to age group.

A Pilot Randomized Controlled Study of Mild Hypercapnia During Cardiac Surgery With Cardiopulmonary Bypass

2019 ◽  
Vol 33 (11) ◽  
pp. 2968-2978
Author(s):  
Matthew J. Chan ◽  
Luca Lucchetta ◽  
Salvatore Cutuli ◽  
Christopher Eyeington ◽  
Neil J. Glassford ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled
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