Background The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients. Objective The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery. Methods This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions. Results The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021. Conclusions This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures. Trial Registration European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168 International Registered Report Identifier (IRRID) DERR1-10.2196/17826

BACKGROUND The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients. OBJECTIVE The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery. METHODS This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable <i>acute cardiovascular event</i>). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions. RESULTS The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021. CONCLUSIONS This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures. CLINICALTRIAL European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17826

BackgroundPancreatic cancer is a disease with a poor prognosis, palliative treatment being the goal of treatment for most patients. Although chemotherapy needs to be tailored to the patient’s preference, treatment tolerance and disease characteristics, prolonged treatment duration may also reflect an increase in progression free survival. Clinical trials with new drugs and new chemotherapy combinations have demonstrated a slight increase in survival in recent years.PurposeTo compare chemotherapy treatment duration in pancreatic cancer patients in two 5 year periods, 2005–2009 and 2010–2014.Material and methodsAll pancreatic cancer patients treated with chemotherapy, at the oncology unit in a 500 bed hospital between January 2005 and December 2014, were included. First and last days of treatment were recorded for each patient in order to calculate treatment duration. Other variables such as gender and age were also collected.Quantitative variables were analysed using the Student’s t test and qualitative variables with the χ2 test, to determine whether there were significant differences in age and sex between the periods. Difference in treatment duration was assessed using the log rank test of survival curve.Results116 patients were included. 50.9% were women, median age was 63.7 years (IQR 56–72) and median treatment duration was 130.5 days (IQR 63.25, 275.75). No statistically significant differences were found for sex (p = 0.679) or age (p = 0.09) between the two study periods. Significant differences in treatment duration were found depending on the period, from 91 (84,119) days before 2010 to 175 (136, 241) days after 2010 (p = 0.04). Survival curve of treatment duration showed significant differences depending on the period (log rank test, p = 0.02).ConclusionChemotherapy treatment duration in pancreatic cancer has been significantly prolonged in the past years. This may be due to the development of new drugs. Whether this is associated with an increase in survival needs to be confirmed in further studies.No conflict of interest.

Objective: to evaluate the adequate cerebral perfusion in patients who underwent cardiac surgery with cardiopulmonary bypass. Methods: an observational, analytical, prospective and multicentric study was conducted. All adults patients scheduled for cardiac surgery with cardiopulmonary bypass were included, with hospital admission at least the day before the intervention, with a negative Pfeiffer test, without communication problems, and with informed consent. Cerebral monitoring with Masimo ROOT 03® was used with encephalogram measurement (4 channels), cerebral oximetry and anesthetic depth. As a pre and postoperative cognitive assessment instrument we used the Pfeiffer test. Results: 19 patients with a mean age of 64.8 ± 11.5 years were included. The postoperative Pfeiffer test showed no cognitive impairment in 78.9% of the cases. While the remaining 21.1% had mild cognitive impairment (1 patient had ischemic damage). In this group, all were valvular patients, older than 65 years of age, and had maximum glycemias greater than 180 mg/dL. In 75% of the patients with cognitive impairment, the baseline SrO2 was less than 57%, there was sustained hypotension at sometime during surgery and it had a decrease of more than 20% of its basal SrO2. Conclusions: Continuous brain monitoring (electroencephalogram, cerebral oxygen saturation, anesthetic depth, suppression rate) during cardiac surgery with cardiopulmonary bypass is a reliable, valid and necessary safety measure to improve the quality of perfusion and surgical patient care.