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  • Klonarakis MP
  • Dhillon M
  • Sevinc E
  • Elliott MJ
  • James MT
  • et al.
Transplant Rev (Orlando). 2024 Feb 5;38(2):100834 doi: 10.1016/j.trre.2024.100834.

Delayed graft function (DGF) is a common post-operative complication with potential long-term sequelae for many kidney transplant recipients, and hemodynamic factors and fluid status play a role. Fixed perioperative fluid infusions are the standard of care, but more recent evidence in the non-transplant population has suggested benefit with goal-directed fluid strategies based on hemodynamic targets. We searched MEDLINE, EMBASE, Cochrane Controlled Trials Registry and Google Scholar through December 2022 for randomized controlled trials comparing risk of DGF between goal-directed and conventional fluid therapy in adults receiving a living or deceased donor kidney transplant. Effect estimates were reported with odds ratios (OR) and pooled using random effects meta-analysis. We identified 4 studies (205 participants) that met the inclusion criteria. The use of goal-directed fluid therapy had no significant effect on DGF (OR 1.37 95% CI, 0.34-5.6; p = 0.52; I2 = 0.11). Subgroup analysis examining effects among deceased and living kidney donation did not reveal significant differences in the effects of fluid strategy on DGF between subgroups. Overall, the strength of the evidence for goal-directed versus conventional fluid therapy to reduce DGF was of low certainty. Our findings highlight the need for larger trials to determine the effect of goal-directed fluid therapy on this patient-centered outcome.

  • Garg AX
  • Yohanna S
  • Naylor KL
  • McKenzie SQ
  • Mucsi I
  • et al.
JAMA Intern Med. 2023 Dec 1;183(12):1366-1375 doi: 10.1001/jamainternmed.2023.5802.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This is a report of a very complex and large study conducted across all transplant centres in Ontario, Canada. Randomization was done by CKD program, to permit the high level interventions that were being initiated.The multicomponent intervention was designed to address complex barriers at multiple levels that prevent kidney transplant and living donation. Support was provided from the central operations group, educational resources were made available and volunteer patients provided support. The primary outcome was assessed at the patient level and assessed the rate of steps completed towards live or deceased transplantation. 9780 patients entered the intervention group of the study during the 4 year inclusion period, and 10595 received usual care. Mean follow up was approximately 2 years. The step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years. There was also no significant difference in the secondary outcomes related to progress towards live donation. Despite a huge investment in monetary terms as well as professional time, and good uptake of interventions at both a program and patient level, there was no improvement in rate of progress towards renal transplantation. The COVID pandemic happened during the trial and is likely to have impacted on the delivery of the interventions. However, it highlights the difficulties of implementing a complex intervention in a healthcare system with multiple drivers and continuous staff turnover.
Aims: The aim of this study was to investigate whether a multicomponent intervention was effective in improving patient access to kidney transplant and living kidney donation.
Interventions: Chronic kidney disease (CKD) programs were randomised to either receive quality improvement intervention in addition to usual care or the usual care alone.
Participants: 26 CKD programs including 20375 potentially transplant-eligible patients with advanced CKD.
Outcomes: The primary endpoint was the rate of steps completed toward receiving a kidney transplant.
Follow Up: 90 days
IMPORTANCE:

Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant.

OBJECTIVES:

To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant.

DESIGN, SETTING, AND PARTICIPANTS:

This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis).

INTERVENTIONS:

Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders.

MAIN OUTCOMES AND MEASURES:

The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor.

RESULTS:

The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15).

CONCLUSIONS AND RELEVANCE:

This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT03329521.

  • Steenvoorden TS
  • van Duin RE
  • Rood JAJ
  • Peters-Sengers H
  • Nurmohamed AS
  • et al.
Br J Clin Pharmacol. 2023 Dec;89(12):3629-3636 doi: 10.1111/bcp.15871.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This is a small study, albeit randomised. Only 5 patients received the alkaline phosphatase treatment and 6 placebo. Given the prior successful use of alkaline phosphatase in cardiac surgery patients could it not have been used in a larger study here, and therefore have more potential to identify any beneficial impact? The study was also conducted only in live kidney transplantation and therefore the potential impact on any ischeamia-reperfusion injury was relatively minimal. Donation after cardiac death is where any potential benefit lies. As it stands, the study showed no real difference between placebo and alkaline phosphatase. The study drug was safely administered in this small group of recipients.
Aims: The aim of this study was to assess the feasibility and safety of alkaline phosphatase for treating ischaemia–reperfusion injury in living donor kidney transplantation.
Interventions: Participants were randomised to either the alkaline phosphatase (bRESCAP) group or the placebo group.
Participants: 11 living donor kiney transplant recipients.
Outcomes: The primary endpoint was 1-year graft function. The secondary endpoints included (serious) AEs (SAEs), and urine and serum biomarkers.
Follow Up: 1 year posttransplantation
AIMS:

Ischemia-reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evaluate the safety and feasibility of peri-procedural AP administration in living donor kidney transplantation.

METHODS:

In this double blind, randomized, placebo-controlled, single-center pilot study, all eligible recipients of living donor kidneys were asked to give informed consent. AP (bRESCAP) or a placebo was administered intravenously over 24 hours after the transplantation procedure. The primary outcome-graft function at 1 year-was represented by iohexol measured glomerular filtration rate (mGFR). Serum and urine biomarkers within seven days after surgery were used as surrogate markers of kidney function and injury.

RESULTS:

Eleven patients were enrolled of whom five were treated with bRESCAP and six with placebo. After 1 year, mGFR was not different between groups. No specific adverse events were observed in the bRESCAP group. Urine expression of injury biomarkers CCL14, NGAL and Cystatin C was lower in the bRESCAP group at day seven. This was statistically significant.

CONCLUSION:

This study illustrates that bRESCAP treatment is feasible in kidney transplantation, might have a dampening effect on IRI induced renal inflammation, and raises no safety concerns. Future research will evaluate the effects of bRESCAP treatment in donation after circulatory death kidney transplantation where IRI is more pronounced.

  • Pérez-Sáez MJ
  • Montero N
  • Oliveras L
  • Redondo-Pachón D
  • Martínez-Simón D
  • et al.
Transplant Rev (Orlando). 2023 Dec;37(4):100787 doi: 10.1016/j.trre.2023.100787.
BACKGROUND:

Kidney transplant (KT) recipients of HLA identical siblings (HLAid) have lower immunological risk, but there are no specific recommendations for immunosuppression. Our aim was to analyze evidence about results from HLAid living-donor recipients under different immunosuppression in the current era of immunological risk assessment.

METHODS:

Systematic review of studies describing associations between outcomes of HLAid living-donor KT recipients according to their immunological risk and applied immunosuppression.

RESULTS:

From 1351 studies, 16 (5636 KT recipients) were included in the analysis. All studies were retrospective, ten comparing immunosuppression strategies, and six immunological risk strata. Of those ten, six studies were published in 1990 or earlier and only three included tacrolimus. The evidence is poor, and the inclusion of calcineurin inhibitors does not demonstrate better results. Furthermore, only few studies describe different immunosuppression regimens according to the patient immunological risk and, in general, they do not include the assessment with new solid phase assays.

CONCLUSIONS:

There are no studies analyzing the association of outcomes of HLAid KT recipients with current immunological risk tools. In the absence of evidence, no decision or proposal of immunosuppression adapted to modern immunological risk assessment can be made currently by the Descartes Working Group.

  • Cazauvieilh V
  • Moal V
  • Prudhomme T
  • Pecoraro A
  • Piana A
  • et al.
Transpl Int. 2023 Nov 24;36:11827 doi: 10.3389/ti.2023.11827.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This is an interesting, well-conducted, and well-written, systematic review in living donation that gives a good description of the complexity in the donor-recipient relationship and the psychological outcome for the donor. Two independent reviewers screened references, extracted data and performed the risk-of bias assessment, which is clearly presented. A broad search was done, albeit only within pubmed/medline. 23 studies were included, comprised of a total 2,732 donors. The authors give a detailed description of the studies in narrative review. There is quantitative evidence from 3 studies that quality of life is the same pre and post-donation, whilst another 4 studies found quantitative evidence of improved quality of life at 1 year post-donation. These studies indicate risk factors that may be predictive of decreased donor quality of life such as donor fatigue, anxiety, depression, lack of social support, the donor-recipient relationship and any complications for the recipient. Three studies found no evidence of an impact of socio-economic status on quality-of-life post-donation. In general, studies found that the relationship between donors and recipients remained unchanged or improved/became closer. Some donors expected that their role as a carer for the recipient would decrease after donation. If this did not happen, donors felt disappointed or frustrated. In the majority of cases, donors were satisfied and did not regret donation. Importantly it was clearly demonstrated that it was possible to regret donation oneself, but to still recommend it for others. All studies showed a low rate of regret. There was some evidence of correlation between regret and the recipient’s outcome from the transplant, but evidence was conflicting. One interesting complexity highlighted by the study is that donors used conscious or unconscious strategies to influence the transplant team to select them as a donor. This may make it difficult to interpret the results of pre and post-donation comparisons. The authors also acknowledge the impact of social desirability bias, which may have affected donor responses to questionnaires.
Aims: This study aimed to examine the psychological effects of donating a kidney on living donors.
Interventions: A literature search was performed using Pubmed and Medline. Study screening and data extraction were performed by two independent reviewers. The ROBINS-I tool was used to assess the risk of bias.
Participants: 23 studies were included in the review.
Outcomes: The main outcomes of interest included assessment of quality of life, anxiety/ depression, regret of donation, psychological impact over failure of transplant/death, and consequence of donation on donor/recipient relationship.
Follow Up: N/A

We performed a systematic literature review of the psychological impact on donors of living kidney donation. We conducted a literature review in PubMed/Medline according to PRISMA guidelines which included both qualitative (based on interviews) and quantitative studies (based on standardized questionnaire). There were 15 quantitative studies and 8 qualitative studies with 2,732 donors. Given that the methodologies of qualitative and quantitative studies are fundamentally different, we narratively synthetized results of studies according to four axes: quality of life, anxiety/depression, consequences of donation on the donor/recipient relationship, overall satisfaction and regret. The quantitative studies reported that donor quality of life remained unchanged or improved. Donor regret rates were very low and donor-recipient relationships also remained unchanged or improved. Qualitative studies reported more complex donation experiences: one can regret donation and still decide to recommend it as in a social desirability bias. In both study types, donor-recipient relationships were closer but qualitative studies reported that post-donation rebonding was required. The qualitative studies therefore highlighted the psychological complexity of donation for donors, showing that living donation impacts the donor's life whether it is successful or not. A better understanding of the impact of donation on donors could provide better care for donors.

  • Selzler AM
  • Davoodi PM
  • Klarenbach S
  • Lam NN
  • Smith T
  • et al.
Can J Kidney Health Dis. 2023 Oct 30;10:20543581231205340 doi: 10.1177/20543581231205340.
BACKGROUND:

Living donor kidney transplantation (LDKT) is the optimal treatment for eligible patients with kidney failure, although it is underutilized. Contextually tailored patient- and family-centered interventions may be effective to increase LDKT.

OBJECTIVE:

We outline a protocol to test the feasibility of the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention designed to increase LDKT.

DESIGN:

Non-blinded single-center pilot randomized controlled trial with a qualitative interview component.

SETTING:

Academic transplant referral center in Northern Alberta Region with a population of more than 2 million in its catchment area.

PATIENTS:

English-speaking patients of the age range 18 to 75 years who are referred for kidney transplantation are eligible to participate.

MEASUREMENTS:

Feasibility will be assessed by indicators of recruitment, retention, and completion rates, treatment fidelity, adherence to intervention, engagement in intervention, and acceptability.

METHODS:

Participants will be randomly assigned 1:1 to either standard care (control) or the experimental group who receive standard care plus the MuST AKT intervention, a person-centered program designed to assist and enable the kidney transplant candidate to achieve what is required to receive an LDKT. The intervention consists of an introductory session and 4 intervention sessions delivered in-person or virtually.

LIMITATIONS:

Inferences cannot be drawn regarding the efficacy/effectiveness of the MuST AKT intervention. This study is non-blinded.

CONCLUSIONS:

This pilot study is the first step in our broader initiative to increase LDKT in our health care jurisdiction. The results of this study will be used to inform the development of a future definitive randomized controlled trial.

TRIAL REGISTRATION NUMBER:

NCT04666545.

  • Daw J
  • Verdery AM
  • Ortiz SE
  • Reed RD
  • Locke JE
  • et al.
Clin Transplant. 2023 Oct;37(10):e15064 doi: 10.1111/ctr.15064.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This paper details the protocol for a very interesting study in live kidney donation. Potential kidney transplant recipients will be randomised into four groups: 1) No intervention, 2) search intervention- advising patients on which social network members are most likely to be contraindication free, 3) script intervention- advises patients on how to initiate effective live kidney donor discussions, 4) both search and script interventions. The primary outcome is the receipt of a live kidney transplant. This study will be conducted in the USA, where there are currently large discrepancies in live donation rates between ethnic groups. The supplemental material online gives an excellent background to the study and thorough explanation of the rationale.
Aims: This protocol aims to provide the rationale behind the design of the Friends and Family of Kidney Transplant Patients Study (FFKTPS) and the planned analyses to test the efficacy of these interventions.
Interventions: Participants will be randomly assigned into four groups: no intervention, search only, script only, or both search and script.
Participants: Kidney transplant candidates.
Outcomes: The primary endpoint is living donor kidney transplantation (LDKT) recipient. The secondary endpoints are live kidney donor (LKD) screening and medical evaluations and outcomes.
Follow Up: 36 months
INTRODUCTION:

Racial/ethnic disparities in living donor kidney transplantation (LDKT) are a persistent challenge. Although nearly all directed donations are from members of patients' social networks, little is known about which social network members take steps toward living kidney donation, which do not, and what mechanisms contribute to racial/ethnic LDKT disparities.

METHODS:

We describe the design and rationale of the Friends and Family of Kidney Transplant Patients Study, a factorial experimental fielding two interventions designed to promote LKD discussions. Participants are kidney transplant candidates at two centers who are interviewed and delivered an intervention by trained center research coordinators. The search intervention advises patients on which social network members are most likely to be LKD contraindication-free; the script intervention advises patients on how to initiate effective LKD discussions. Participants are randomized into four conditions: no intervention, search only, script only, or both search and script. Patients also complete a survey and optionally provide social network member contact information so they can be surveyed directly. This study will seek to enroll 200 transplant candidates. The primary outcome is LDKT receipt. Secondary outcomes include live donor screening and medical evaluations and outcomes. Tertiary outcomes include LDKT self-efficacy, concerns, knowledge, and willingness, measured before and after the interventions.

CONCLUSION:

This study will assess the effectiveness of two interventions to promote LKD and ameliorate Black-White disparities. It will also collect unprecedented information on transplant candidates' social network members, enabling future work to address network member structural barriers to LKD.

  • Pillai A
  • Verna EC
  • Parikh ND
  • Cooper M
  • Thiessen C
  • et al.
Clin Transplant. 2023 Jul;37(7):e14955 doi: 10.1111/ctr.14955.
INTRODUCTION:

In October 2021, the American Society of Transplantation (AST) hosted a virtual consensus conference aimed at identifying and addressing barriers to the broader, safe expansion of living donor liver transplantation (LDLT) throughout the United States (US).

METHODS:

A multidisciplinary group of LDLT experts convened to address issues related to financial implications on the donor, transplant center crisis management, regulatory and oversight policies, and ethical considerations by assessing the relative significance of issues in preventing LDLT growth, with proposed strategies to overcome barriers.

RESULTS:

Living liver donors endure multiple obstacles including financial instability, loss of job security, and potential morbidity. These concerns, along with other center, state, and federal specific policies can be perceived as significant barriers to expanding LDLT. Donor safety is of paramount importance to the transplant community; however, regulatory and oversight policies aimed at ensuring donor safety can be viewed as ambiguous and complicated leading to time-consuming evaluations that may deter donor motivation and program expansion.

CONCLUSION:

Transplant programs need to establish appropriate crisis management plans to mitigate potential negative donor outcomes and ensure program viability and stability. Finally, ethical aspects, including informed consent for high-risk recipients and use of non-directed donors, can be perceived as additional barriers to expanding LDLT.

  • Kulkarni S
  • Flescher A
  • Ahmad M
  • Bayliss G
  • Bearl D
  • et al.
J Med Ethics. 2023 Jun;49(6):389-392 doi: 10.1136/medethics-2021-107574.

The transplant community has faced unprecedented challenges balancing risks of performing living donor transplants during the COVID-19 pandemic with harms of temporarily suspending these procedures. Decisions regarding postponement of living donation stem from its designation as an elective procedure, this despite that the Centers for Medicare and Medicaid Services categorise transplant procedures as tier 3b (high medical urgency-do not postpone). In times of severe resource constraints, health systems may be operating under crisis or contingency standards of care. In this manuscript, the United Network for Organ Sharing Ethics Workgroup explores prioritisation of living donation where health systems operate under contingency standards of care and provide a framework with recommendations to the transplant community on how to approach living donation in these circumstances.To guide the transplant community in future decisions, this analysis suggests that: (1) living donor transplants represent an important option for individuals with end-stage liver and kidney disease and should not be suspended uniformly under contingency standards, (2) exposure risk to SARS-CoV-2 should be balanced with other risks, such as exposure risks at dialysis centres. Because many of these risks are not quantifiable, donors and recipients should be included in discussions on what constitutes acceptable risk, (3) transplant hospitals should strive to maintain a critical transplant workforce and avoid diverting expertise, which could negatively impact patient preparedness for transplant, (4) transplant hospitals should consider implementing protocols to ensure early detection of SARS-CoV-2 infections and discuss these measures with donors and recipients in a process of shared decision-making.

  • Park JY
  • Yang WJ
  • Doo SW
  • Park JJ
  • Gwon YN
  • et al.
BMC Nephrol. 2023 May 30;24(1):152 doi: 10.1186/s12882-023-03208-z.
BACKGROUND:

Recent studies have shown that donor nephrectomy can induce renal function impairment. However, few meta-analysis studies about this have proceeded. Therefore, the objective of this systematic review and meta-analysis including all data of recent research studies was to determine whether living donor nephrectomy (LDN) could induce renal function impairment.

METHODS:

By November 2020, comprehensive literature searches were performed on PubMed, Embase, and Cochrane databases. Inclusion criteria were: (1) observational studies with data about overall end-stage renal disease (ESRD) or chronic kidney disease (CKD) of living kidney donors, (2) control group consisted of people without donor nephrectomy, and (3) outcomes of studies included long-term end-stage renal disease risks after living kidney donation. Risk of Bias in Non-randomized Studies of interventions (ROBINS-I) assessment tool was used to evaluate our methodological quality.

RESULTS:

The qualitative review included 11 studies and the meta-analysis included 5 studies. In the meta-analysis, the integrated overall ESRD risk was 5.57 (95% CI: 2.03-15.30). Regarding the overall risk of bias using ROBINS-I assessment tool, 0 studies was rated as "Low", 7 studies were rated as "moderate", 2 studies were rated as "Serious", and two studies were rated as "Critical".

CONCLUSIONS:

Our study showed that LDN increased ESRD risk in LDN patients. However, in our meta-analysis, variables in included studies were not uniform and the number of included studies was small. To have a definite conclusion, meta-analyses of well-planned and detailed studies need to be conducted in the future.