IMPORTANCE:

The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear.

OBJECTIVE:

To evaluate the effectiveness of an evidence-based, goal-directed checklist in the clinical management of brain-dead potential donors in the intensive care unit (ICU).

DESIGN, SETTING, AND PARTICIPANTS:

The Donation Network to Optimize Organ Recovery Study (DONORS) was an open-label, parallel-group cluster randomized clinical trial in Brazil. Enrollment and follow-up were conducted from June 20, 2017, to November 30, 2019. Hospital ICUs that reported 10 or more brain deaths in the previous 2 years were included. Consecutive brain-dead potential donors in the ICU aged 14 to 90 years with a condition consistent with brain death after the first clinical examination were enrolled. Participants were randomized to either the intervention group or the control group. The intention-to-treat data analysis was conducted from June 15 to August 30, 2020.

INTERVENTIONS:

Hospital staff in the intervention group were instructed to administer to brain-dead potential donors in the intervention group an evidence-based checklist with 13 clinical goals and 14 corresponding actions to guide care, every 6 hours, from study enrollment to organ retrieval. The control group provided or received usual care.

MAIN OUTCOMES AND MEASURES:

The primary outcome was loss of brain-dead potential donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed the effect of adherence to the checklist in the intervention group.

RESULTS:

Among the 1771 brain-dead potential donors screened in 63 hospitals, 1535 were included. These patients included 673 males (59.2%) and had a median (IQR) age of 51 (36.3-62.0) years. The main cause of brain injury was stroke (877 [57.1%]), followed by trauma (485 [31.6%]). Of the 63 hospitals, 31 (49.2%) were assigned to the intervention group (743 [48.4%] brain-dead potential donors) and 32 (50.8%) to the control group (792 [51.6%] brain-dead potential donors). Seventy potential donors (9.4%) at intervention hospitals and 117 (14.8%) at control hospitals met the primary outcome (risk ratio [RR], 0.70; 95% CI, 0.46-1.08; P = .11). The primary outcome rate was lower in those with adherence higher than 79.0% than in the control group (5.3% vs 14.8%; RR, 0.41; 95% CI, 0.22-0.78; P = .006).

CONCLUSIONS AND RELEVANCE:

This cluster randomized clinical trial was inconclusive in determining whether the overall use of an evidence-based, goal-directed checklist reduced brain-dead potential donor loss to cardiac arrest. The findings suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT03179020.

INTRODUCTION:

Simultaneous pancreas kidney (SPK) transplantation is an invaluable procedure to enhance the quality of life of insulin-dependent patients with advanced renal disease. The creation of vascular anastomoses of the donor's pancreas vessels to the recipient's, is of utmost importance to predict the graft outcome and surgical complications. In the study we introduce a novel technique for arterial reconstruction during SPK transplantation.

METHODS:

Conventionally, during the SPK transplantation, a so-called Y-graft is anastomosed between donor's superior mesenteric and splenic artery to the recipient's right iliac artery. In the study we adopted a new technique by preparing an extra extension using the donor's carotid artery, to be anastomosed to the Y-graft and the iliac artery. In this non-blinded randomized clinical trial we compared the surgical complications and early outcomes between the 2 groups of patients with the traditional and new arterial reconstruction techniques during 3 months after transplantation.

RESULTS:

Thirty adult patients were included in the study. The incidence of pancreatitis, vascular thrombosis and surgical site infection was lower in the new Y-graft and extension technique, which was not statistically significant. However, the calculated Cohen's d index showed the medium effect of new Y-graft and extension technique on complication after SPK transplantations.

CONCLUSION:

The post-operative complications tend to be lower in the novel arterial reconstruction technique, however a study on a larger patient group is encouraged to confirm our primary results.

TRIAL REGISTRATION:

The study was registered at the Iranian Registry of Clinical Trials on 12/05/2022; IRCT 20210625051701N2; ( http://www.irct.ir/ ).

BACKGROUND:

The Hispanic community has a high demand for organ donation but a shortage of donors. Studies investigating factors that could promote or hinder organ donation have examined emotional video interventions. Factors acting as barriers to organ donation registration have been classified as: (1) Bodily integrity; (2) medical mistrust; (3) "ick"-feelings of disgust towards organ donation; and (4) "jinx"-fear that registration may result in one dying due to premeditated plans. We predict that by providing necessary information and education about the donation process via a short video, individuals will be more willing to register as organ donors.

AIM:

To determine perceptions and attitudes regarding barriers and facilitators to organ donation intention among Hispanic residents in the New York metro politan area.

METHODS:

This study was approved by the Institutional Review Board at Northwell Health. The approval reference number is No. 19-0009 (as presented in Supplementary material). Eligible participants included Hispanic New York City (NYC) residents, 18 years of age and above, who were recruited voluntarily through Cloud Research and participated in a larger randomized survey study of NYC residents. The survey an 85-item Redcap survey measured participant demographics, attitudes, and knowledge of organ donation as well as the intention to register as an organ donor. Attention checks were implemented throughout the survey, and responses were excluded for those who did fail. Participants were randomly assigned two-between subject conditions: To view a short video on organ donation and then proceed to complete the survey (i.e., video first) and view the same video at the end of the survey (video last). No intra-group activities were conducted. This study utilized an evidenced-based emotive educational intervention (video) which was previously utilized and was shown to increase organ donation registration rates at the Ohio Department of Motor Vehicles. Results were analyzed using Jamovi statistical software. Three hundred sixty-five Hispanic individuals were included in the analysis. Once consent was obtained and participants entered the survey (the survey sample is presented in Supplementary material), participants were asked to report on demographic variables and their general impression of organ donation after death. The video depicted stories regarding organ donation after death from various viewpoints, including from the loved ones of a deceased person who died waiting for a transplant; from the loved ones of a deceased person whose organs were donated upon death; and, from those who were currently waiting for a transplant.

RESULTS:

Using a binomial logistic regression, the analysis provides information about the relationship between the effects of an emotive video and the intention to donate among Hispanic participants who were not already registered as donors. The willingness to go back and register was found to be significantly more probable for those who watched the emotive video before being asked about their organ donation opinions (odds ratio: 2.05, 95% confidence interval: 1.06-3.97). Motivations for participation in organ donation were also captured with many stating the importance of messages coming from "people like me" and a message that highlights "the welfare of those in need". Overall, the findings suggest that using an emotive video that addresses organ donation barriers to prompt organ donation intentions can be effective among the Hispanic populous. Future studies should explore using targeted messaging that resonates with specific cultural groups, highlighting the welfare of others.

CONCLUSION:

This study suggests that an emotive educational intervention is likely to be effective in improving organ donation registration intent among the Hispanic population residing in NYC.

BACKGROUND:

Simultaneous pancreas and kidney transplantation (SPKT) is an effective treatment option for individuals who suffer from both diabetes mellitus and renal failure. However, experiments exploring nurse-led multidisciplinary team management during the perioperative management of patients undergoing SPKT are currently limited. This study aims to explore the clinical performance of a transplant nurse-led multidisciplinary team (MDT) in the perioperative management of SPKT patients.

METHODS:

A total of 218 patients who underwent SPKT were randomly assigned to either a control group (n=116) receiving conventional care or an intervention group (n=102) managed through a transplant nurse-led MDT approach. The incidence of postoperative complications, hospital stay, total hospitalization cost, readmission rate, and postoperative nursing quality were compared between these 2 groups.

RESULTS:

The intervention and control groups showed no significant differences in age, gender, and body mass index. Compared with the control group, the intervention group had a significantly lower incidence of postoperative pulmonary infection and gastrointestinal (GI) bleeding (27.6% vs. 14.7% and 31.0% vs. 15.7%, respectively, both P<0.05). Compared to the control group, the intervention group had significantly lower hospitalization costs, length of hospital stay, and readmission rate 30 days after discharge (32.98±9.10 vs. 36.78±15.36, 26.47±13.4 vs. 31.03±11.61 and 31.4% vs. 50.0%, respectively, all P<0.05). Additionally, the intervention group had significantly better quality of postoperative nursing care than the control group (11.61±0.69 vs. 9.64±1.42, P<0.01), the availability of infection control and prevention measures (11.74±0.61 vs. 10.53±1.11, P<0.01), the effectiveness of health education (11.73±0.61 vs. 10.41±1.06, P<0.01), the effectiveness of rehabilitation training (11.77±0.54 vs. 10.37±0.96, P<0.01), and the patient satisfaction with nursing care (11.83±0.42 vs. 10.81±1.08, P<0.01).

CONCLUSIONS:

The nurse-led MDT model for transplant patients can reduce complications, shorten hospital stays, and save costs. It also provides clear guidelines for nurses, improving care quality and aiding patient recovery.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry ChiCTR1900026543.

BACKGROUND Simultaneous pancreas-kidney transplantation (SPK) is a time-consuming and important surgical procedure, which can provide a physiological mean of achieving normoglycemia and render patients free of dialysis. The potential clinical benefits of sugammadex include fast and predictable reverse deep neuromuscular blockade (NMB), but whether sugammadex affects the function of SPK grafts is uncertain. MATERIAL AND METHODS Forty-eight patients were studied and reversed deep NMB with either sugammadex (n=24) or neostigmine (n=24). The safety variables included serum creatinine (Scr), creatinine clearance rate (CCr), serum amylase (AMS), blood glucose (Glu), mean arterial pressure (MAP), and heart rate (HR). Secondary outcomes were time from administration of sugammadex/neostigmine at the scheduled time to recovery of a TOF ratio to 0.7 and 0.9, and post-acute pulmonary complications. RESULTS Scr at T2-6 was significantly lower than that at T0-1 (P<0.01), while CCr was higher (P<0.05). Between the 2 groups, Scr, CCr, and AMS were similar at the same timepoints (P>0.05). MAP, HR, and Glu were higher in group S than in group N at T1 (P<0.05). The recovery time of TOF=0.7 was 3 (2.4-4.2) min for group S and 12.1 (10.2-15.9) min for group N (P<0.001), and recovery time to TOFr ≥0.9 was 4.8 (3.6-7.1) min for group S and 23.5 (19.8-30.8) in group S. Compared to group N, group S had lower risk for post-acute pulmonary complications: supplemental oxygen requirements 0 vs 4 (16.7%), pulmonary atelectasis 0 vs 2 (0.83%), pneumonia 1 (4.2%) vs 3 (12.5%), and hypoxemia 1 (4.2%) vs 4 (16.7%). CONCLUSIONS Sugammadex administration is safe and effective for SPK transplantation recipients.

RATIONALE:

Family, and sometimes longstanding friends, have considerable influence over organ donation, through agreeing or disagreeing to the donation of a deceased individual's organs. To date, most research has been undertaken within opt-in systems.

OBJECTIVE:

This study advances on previous research by assessing next-of-kin approval under opt-out legislation. We tested whether next-of-kin approval varies when the deceased is a registered donor (opted-in), registered non-donor (opted-out) or has not registered a decision under an opt-out policy (deemed consent). We also tested if the deceased's wishes influenced next-of-kin approval through relatives anticipating regret for not donating and feelings of uncertainty. Finally, we assessed whether next-of-kin's own beliefs about organ donation influenced whether they followed the deceased's wishes.

METHODS:

Participants (N = 848) living in a country with opt-out legislation (Wales, UK) were asked to imagine a relative had died under an opt-out system and decided if their relatives' organs should be donated. Participants were randomly allocated to imagine the deceased had either (i) opted-in, (ii) opted-out or (iii) not registered a decision (deemed consent). The outcome variable was next-of-kin approval, with uncertainty and anticipated regret as potential mediators and next-of-kin's beliefs about organ donation as moderators.

RESULTS:

Next-of-kin approval was lower when the deceased had opted-out than under deemed consent. This was due to next-of-kin anticipating more regret for not donating under deemed consent than opt-out. Further analyses revealed the deceased's wishes influence next-of-kin approval, via anticipated regret, when next-of-kin did not hold negative beliefs about organ donation.

CONCLUSIONS:

The deceased's wishes were less likely to be followed when next-of-kin had negative beliefs towards donation. Developing large-scale campaigns to improve these beliefs in the general public should make people more likely to follow the deceased's wishes. As a result, these campaigns should improve the availability of donor organs.

BACKGROUND:

Diabetes is one of the most common chronic diseases in the world. End-stage renal disease (ESRD) caused by diabetes is the most serious long-term complication. The main cause of death in patients with simultaneous pancreas-kidney transplantation (SPKT) is cardiovascular disease. Although dexmedetomidine (Dex) has unique advantages in heart protection against ischaemic/reperfusion injury, few clinical studies have been conducted on its cardioprotective effect in SPKT. This study aimed to explore the influence of Dex on myocardial injury in patients undergoing SPKT and to analyze its possible mechanism.

METHODS:

A randomized controlled trial (RCT) was performed from July 1, 2018 to December 1, 2020. Eighty patients, regardless of gender, scheduled for SPKT were randomly allocated into a Dex group (D group) receiving Dex at a rate of 1 µg/kg for 10 minutes before anaesthesia induction and then continuous infusion at 0.5 µg/kg/hour until the end of surgery and control group (C group) receiving equivalent capacity of saline. Serum cardiac troponin I (cTnI), creatine kinase isoenzyme (CK-MB), tumour necrosis factor-α (TNF-α), and interleukin-6 (IL-6) were recorded at 5 minutes after anaesthesia induction (baseline,T0), 5 minutes before renal arteriovenous opening (T1), 30 minutes after renal arteriovenous opening (T2), 30 minutes after pancreatic related arteriovenous opening (T3), immediately after surgery (T4), 4 hours after surgery (T5), and 24 hours after surgery (T6). Adverse cardiovascular events were recorded during the perioperative period. Changes in ECG S-T segments and T waves were monitored at T0-T6. Myocardial infarction and percutaneous coronary intervention were recorded with an average follow-up of one year.

RESULTS:

Compared with T0, TNF-α and IL-6 concentrations significantly increased at T1-T6 in the C and D groups (P < 0.05). IL-6 concentration increased significantly after renal artery opening and reached the peak after the opening of pancreatic blood vessels. Compared with the C group, TNF-α, and IL-6 concentrations were significantly reduced in group D at T2-T6 (P < 0.05). Compared with T0, cTnI and CK-MB concentrations were significantly increased at T3-T6 in the C and D groups (P < 0.05). cTnI and CK-MB concentrations increased significantly after the opening of renal artery, and reached the peak after the opening of pancreatic blood vessels. Compared with the C group, cTnI and CK-MB concentrations were significantly reduced in the D group at T3-T6 (P < 0.05). There was no significant difference in patient characteristics amongst groups, including the proportion of intraoperative vasoactive drug use and adverse cardiovascular events during the follow-up period. Heart rate, mean blood pressure, central venous pressure, and cardiac output were not remarkably different between the two groups at any time point.

CONCLUSIONS:

Perioperative reperfusion could aggravate myocardial injury in SPKT. Dex may be considered a way to reduce myocardial injury caused by inflammatory action by decreasing the release of inflammatory factors. Trial Registration Number: Chinese Clinical Trial Registry ID: ChiCTR2200060084.

BACKGROUND:

Therapies for refractory cytomegalovirus infections (with or without resistance [R/R]) in transplant recipients are limited by toxicities. Maribavir has multimodal anti-cytomegalovirus activity through the inhibition of UL97 protein kinase.

METHODS:

In this phase 3, open-label study, hematopoietic-cell and solid-organ transplant recipients with R/R cytomegalovirus were randomized 2:1 to maribavir 400 mg twice daily or investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for 8 weeks, with 12 weeks of follow-up. The primary endpoint was confirmed cytomegalovirus clearance at end of week 8. The key secondary endpoint was achievement of cytomegalovirus clearance and symptom control at end of week 8, maintained through week 16.

RESULTS:

352 patients were randomized (235 maribavir; 117 IAT). Significantly more patients in the maribavir versus IAT group achieved the primary endpoint (55.7% vs 23.9%; adjusted difference [95% confidence interval (CI)]: 32.8% [22.80-42.74]; P < .001) and key secondary endpoint (18.7% vs 10.3%; adjusted difference [95% CI]: 9.5% [2.02-16.88]; P = .01). Rates of treatment-emergent adverse events (TEAEs) were similar between groups (maribavir, 97.4%; IAT, 91.4%). Maribavir was associated with less acute kidney injury versus foscarnet (8.5% vs 21.3%) and neutropenia versus valganciclovir/ganciclovir (9.4% vs 33.9%). Fewer patients discontinued treatment due to TEAEs with maribavir (13.2%) than IAT (31.9%). One patient per group had fatal treatment-related TEAEs.

CONCLUSIONS:

Maribavir was superior to IAT for cytomegalovirus viremia clearance and viremia clearance plus symptom control maintained post-therapy in transplant recipients with R/R cytomegalovirus. Maribavir had fewer treatment discontinuations due to TEAEs than IAT. Clinical Trials Registration. NCT02931539 (SOLSTICE).

Maintenance of postoperative graft flow is important in pancreas transplantation. In Japan, reconstruction of the common hepatic artery is performed primarily to increase perfusion in the pancreatic head. We investigated the effects of common hepatic artery reconstruction on patient and graft survival and endocrine functions. Twenty-nine cases of pancreas transplantation were registered in the clinical trial. Of the 29 cases, four were excluded because of the risk of ischemia without reconstruction or complicated reconstruction due to a narrow artery. A total of 25 cases were randomized into two groups: 13 in the non-reconstructed group and 12 in the reconstructed group. The 1-year patient survival and graft survival rates of the non-reconstructed and reconstructed groups were 92.3% and 83.3%, and 91.7% and 82.5%, respectively. The incidence of complications in the two groups was comparable, with 38.5% (5/13 cases) in the non-reconstructed group and 33.3% (4/12 cases) in the reconstructed group. The results of the glucagon stimulation test and oral glucose tolerance test at 1 month and 1 year post-transplantation were comparable. Common hepatic artery reconstruction is not essential unless there is risk of ischemia. This study was registered at the University Hospital Medical Information Network Clinical Trials Registry under UMIN000027213.