scholarly journals Effects of Perioperative Transcutaneous Electrical Acupoint Stimulation on Monocytic HLA-DR Expression in Patients undergoing Coronary Artery Bypass Grafting with Cardiopulmonary Bypass: Study Protocol for a Double-blind Randomized Controlled Trial

2019 ◽  
Author(s):  
Wen-ting Chen ◽  
Jin-feng Wei ◽  
Lan Wang ◽  
Deng-wen Zhang ◽  
Wei Tang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Infectious Complications ◽  
Invasive Technique ◽  
Effective Prevention ◽  
Hla Dr ◽  
Acupoint Stimulation

Abstract Abstract Background: Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), even mortality. The effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture related techniques, such as electroacupuncture (EA) and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized “global” biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump CABG. Methods: This clinical study was a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB were randomized into 2 groups: the group of TEAS, and the group of transcutaneous acupoint pseudo - electric stimulation (Sham TEAS). Monocytic HLA-DR expression serves as a primary endpoint, and other laboratory parameters (e.g. IL-6, IL-10) and clinical outcomes (e.g. postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, some immune indicators, such as high mobility group protein 1 (HMGB1) and regulatory T cell (Treg), possibly related to the mechanism of TEAS, will also be measured. Discussion: The current study is a preliminary mono-centric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large sample clinical trial with using relevant patient-centered clinical outcomes as primary endpoints. Trial registration: This study was approved by Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine with the number 2016-455-06-01. The results of the trial will be published in an internationally peer-reviewed journal. This study was registered at ClinicalTrials with the Identifier NCT02933996 on 13 October 2016, https://www.clinicaltrials.gov/ct2/show/NCT02933996 Keywords: CABG; TEAS; immunosuppression; mHLA-DR

scholarly journals Effects of Perioperative Transcutaneous Electrical Acupoint Stimulation on Monocytic HLA-DR Expression in Patients undergoing Coronary Artery Bypass Grafting with Cardiopulmonary Bypass: Study Protocol for a Double-blind Randomized Controlled Trial

2019 ◽  
Author(s):  
Wen-ting Chen ◽  
Jin-feng Wei ◽  
Lan Wang ◽  
Deng-wen Zhang ◽  
Wei Tang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Coronary Artery ◽  
Coronary Artery Bypass Grafting ◽  
Artery Bypass ◽  
Infectious Complications ◽  
Bypass Grafting ◽  
Hla Dr ◽  
Acupoint Stimulation

Abstract Background: Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), even mortality. The effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture related techniques, such as electroacupuncture (EA) and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized “global” biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump Coronary Artery Bypass Grafting (CABG). Methods: This clinical study was a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into 2 groups: the group of TEAS, and the group of transcutaneous acupoint pseudo - electric stimulation (Sham TEAS). Monocytic HLA-DR expression serves as a primary endpoint, and other laboratory parameters (e.g. IL-6, IL-10) and clinical outcomes (e.g. postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group protein 1 (HMGB1) and regulatory T cell (Treg) will also be measured. Discussion: The current study is a preliminary mono-centric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large sample clinical trial with using relevant patient-centered clinical outcomes as primary endpoints.

scholarly journals Effects of perioperative transcutaneous electrical acupoint stimulation on monocytic HLA-DR expression in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass: study protocol for a double-blind randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Wen-ting Chen ◽  
Jin-feng Wei ◽  
Lan Wang ◽  
Deng-wen Zhang ◽  
Wei Tang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Coronary Artery ◽  
Coronary Artery Bypass Grafting ◽  
Clinical Outcomes ◽  
Artery Bypass ◽  
Infectious Complications ◽  
Bypass Grafting ◽  
Acupoint Stimulation

Abstract Background Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), and even mortality. Effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture-related techniques, such as electroacupuncture and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post-cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized “global” biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump coronary artery bypass grafting (CABG). Methods This study is a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into two groups: the group receiving TEAS, and the group receiving transcutaneous acupoint pseudo-electric stimulation (Sham TEAS). Expression of mHLA-DR serves as a primary endpoint, and other laboratory parameters (e.g., interleukin [IL]-6, IL-10) and clinical outcomes (e.g., postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group box 1 protein and regulatory T cells will also be measured. Discussion The current study is a preliminary monocentric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large-sample clinical trials using relevant patient-centered clinical outcomes as primary endpoints. Trial registration ClinicalTrials.gov, NCT02933996. Registered on 13 October 2016.

Abstract 14873: Is There Difference in Clinical Outcomes Following Percutaneous Coronary Intervention (PCI) for Acute Coronary Syndrome (ACS) between Hospitals With and Without Onsite Cardiac Surgery Backup?

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Tomonori Akasaka ◽  
Seiji Hokimoto ◽  
Noriaki Tabata ◽  
Kenji Sakamoto ◽  
Kenichi Tsujita ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards Model ◽  
Bleeding Complications ◽  
Hospital Death ◽  
Coronary Syndrome ◽  
Significant Difference ◽  
The Impact

Background: Based on 2011 ACCF/AHA/SCAI PCI guideline, it is recommended that PCI should be performed at hospital with onsite cardiac surgery. But, recent data suggests that there is no significant difference in clinical outcomes following primary or elective PCI between hospitals with and without onsite cardiac surgery. The proportion of PCI centers without onsite cardiac surgery comprises approximately more than half of all PCI centers in Japan. We examined the impact of with or without onsite cardiac surgery on clinical outcomes following PCI to ACS. Methods: From Aug 2008 to March 2011, subjects (n=2288) were enrolled from the Kumamoto Intervention Conference Study (KICS), which is a multicenter registry, and enrolling consecutive patients undergoing PCI in 15 centers in Japan. Patients were assigned to two groups treated in hospitals with (n=1954) or without (n=334) onsite cardiac surgery. Clinical events were followed up for 12 months. Primary endpoint was in-hospital death, cardiovascular death, myocardial infarction, and stroke. And we monitored other events those were non-cardiovascular deaths, bleeding complications, revascularizations, and emergent CABG. Results: There was no overall significant difference in primary endpoint between hospitals with and without onsite cardiac surgery (9.6%vs9.5%; P=0.737). There was also no significant difference when events in primary endpoint were considered separately. In other events, only revascularization was more frequently seen in hospitals with onsite cardiac surgery (22.1%vs12.9%; P<0.001). Kaplan-Meier analysis for primary endpoint showed that there was no significant difference between two groups (Log Rank P=0.943). By cox proportional hazards model analysis for primary endpoint, without onsite cardiac surgery was not a predictive factor for primary endpoint (HR 0.969, 95%CI 0.704-1.333; P=0.845). We performed propensity score matching analysis to correct for the disparate patient numbers between two groups, and there was also no significant difference for primary endpoint (6.9% vs 8.0%; P=0.544). Conclusions: There is no significant difference in clinical outcomes following PCI for ACS between hospitals with and without onsite cardiac surgery backup in Japan.

Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial

2019 ◽  
Vol 45 (10) ◽  
pp. 1413-1421 ◽  
Author(s):  
Osama Abou-Arab ◽  
Pierre Huette ◽  
Lucie Martineau ◽  
Clémence Beauvalot ◽  
Christophe Beyls ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Randomized Clinical Trial ◽  
Cardiovascular Complications

scholarly journals Intermediate-risk meningioma: initial outcomes from NRG Oncology RTOG 0539

2018 ◽  
Vol 129 (1) ◽  
pp. 35-47 ◽  
Author(s):  
Leland Rogers ◽  
Peixin Zhang ◽  
Michael A. Vogelbaum ◽  
Arie Perry ◽  
Lynn S. Ashby ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Risk Group ◽  
Local Failure ◽  
Intermediate Risk ◽  
Newly Diagnosed ◽  
Who Grade ◽  
Significant Difference ◽  
Grade Ii

OBJECTIVEThis is the first clinical outcomes report of NRG Oncology RTOG 0539, detailing the primary endpoint, 3-year progression-free survival (PFS), compared with a predefined historical control for intermediate-risk meningioma, and secondarily evaluating overall survival (OS), local failure, and prospectively scored adverse events (AEs).METHODSNRG Oncology RTOG 0539 was a Phase II clinical trial allocating meningioma patients to 1 of 3 prognostic groups and management strategies according to WHO grade, recurrence status, and resection extent. For the intermediate-risk group (Group 2), eligible patients had either newly diagnosed WHO Grade II meningioma that had been treated with gross-total resection (GTR; Simpson Grades I–III) or recurrent WHO Grade I meningioma with any resection extent. Pathology and imaging were centrally reviewed. Patients were treated with radiation therapy (RT), either intensity modulated (IMRT) or 3D conformal (3DCRT), 54 Gy in 30 fractions. The RT target volume was defined as the tumor bed and any nodular enhancement (e.g., in patients with recurrent WHO Grade I tumors) with a minimum 8-mm and maximum 15-mm margin, depending on tumor location and setup reproducibility of the RT method. The primary endpoint was 3-year PFS. Results were compared with historical controls (3-year PFS: 70% following GTR alone and 90% with GTR + RT). AEs were scored using NCI Common Toxicity Criteria.RESULTSFifty-six patients enrolled in the intermediate-risk group, of whom 3 were ineligible and 1 did not receive RT. Of the 52 patients who received protocol therapy, 4 withdrew without a recurrence before 3 years leaving 48 patients evaluable for the primary endpoint, 3-year PFS, which was actuarially 93.8% (p = 0.0003). Within 3 years, 3 patients experienced events affecting PFS: 1 patient with a WHO Grade II tumor died of the disease, 1 patient with a WHO Grade II tumor had disease progression but remained alive, and 1 patient with recurrent WHO Grade I meningioma died of undetermined cause without tumor progression. The 3-year actuarial local failure rate was 4.1%, and the 3-year OS rate was 96%. After 3 years, progression occurred in 2 additional patients: 1 patient with recurrent WHO Grade I meningioma and 1 patient with WHO Grade II disease; both remain alive. Among 52 evaluable patients who received protocol treatment, 36 (69.2%) had WHO Grade II tumors and underwent GTR, and 16 (30.8%) had recurrent WHO Grade I tumors. There was no significant difference in PFS between these subgroups (p = 0.52, HR 0.56, 95% CI 0.09–3.35), validating their consolidation. Of the 52 evaluable patients, 44 (84.6%) received IMRT, and 50 (96.2%) were treated per protocol or with acceptable variation. AEs (definitely, probably, or possibly related to protocol treatment) were limited to Grade 1 or 2, with no reported Grade 3 events.CONCLUSIONSThis is the first clinical outcomes report from NRG Oncology RTOG 0539. Patients with intermediate-risk meningioma treated with RT had excellent 3-year PFS, with a low rate of local failure and a low risk of AEs. These results support the use of postoperative RT for newly diagnosed gross-totally resected WHO Grade II or recurrent WHO Grade I meningioma irrespective of resection extent. They also document minimal toxicity and high rates of tumor control with IMRT.Clinical trial registration no.: NCT00895622 (clinicaltrials.gov).

scholarly journals Severity of hyperoxia as a risk factor in patients undergoing on-pump cardiac surgery

2017 ◽  
Vol 24 (3) ◽  
pp. 153-158
Author(s):  
Gabrielius Jakutis ◽  
Ieva Norkienė ◽  
Donata Ringaitienė ◽  
Tomas Jovaiša
Keyword(s):  
Mechanical Ventilation ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Hospital Stay ◽  
Prolonged Mechanical Ventilation ◽  
Length Of Hospital Stay ◽  
Infectious Complications ◽  
Research Database ◽  
Elective Cardiac Surgery ◽  
The Impact

Background. Hyperoxia has long been perceived as a desirable or at least an inevitable part of cardiopulmonary bypass. Recent evidence suggest that it might have multiple detrimental effects on patient homeostasis. The aim of the study was to identify the determinants of supra-physiological values of partial oxygen pressure during on-pump cardiac surgery and to assess the impact of hyperoxia on clinical outcomes. Materials and methods. Retrospective data analysis of the institutional research database was performed to evaluate the effects of hyperoxia in patients undergoing elective cardiac surgery with cardiopulmonary bypass, 246 patients were included in the final analysis. Patients were divided in three groups: mild hyperoxia (MHO, PaO2 100–199 mmHg), moderate hyperoxia (MdHO, PaO2 200–299 mmHg), and severe hyperoxia (SHO, PaO2 >300 mmHg). Postoperative complications and outcomes were defined according to standardised criteria of the Society of Thoracic Surgeons. Results. The extent of hyperoxia was more immense in patients with a lower body mass index (p = 0.001) and of female sex (p = 0.005). A significant link between severe hyperoxia and a higher incidence of infectious complications (p – 0.044), an increased length of hospital stay (p – 0.044) and extended duration of mechanical ventilation (p < 0.001) was confirmed. Conclusions. Severe hyperoxia is associated with an increased incidence of postoperative infectious complications, prolonged mechanical ventilation, and increased hospital stay.

scholarly journals Feasibility of On-table Extubation After Cardiac Surgery with Cardiopulmonary Bypass: A Randomized Clinical Trial

2018 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Ziae Totonchi ◽  
Rasoul Azarfarin ◽  
Louise Jafari ◽  
Alireza Alizadeh Ghavidel ◽  
Bahador Baharestani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Randomized Clinical Trial
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