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To keep the transplantation community informed about recently published level 1 evidence in organ transplantation ESOT and the
Sodium Bicarbonate for Kidney Transplant Recipients With Metabolic Acidosis in Switzerland: A Multicentre, Randomised, Single-Blind, Placebo-Controlled, Phase 3 Trial.
The aim of this study was to examine the effects of sodium bicarbonate treatment on graft function in renal transplant patients with metabolic acidosis.
Participants were randomised to receive either oral sodium bicarbonate or matching placebo.
242 kidney transplant recipients with metabolic acidosis.
The primary outcome was the estimated glomerular filtration rate (GFR) slope over a treatment phase of 24 months. Secondary outcomes were serum bicarbonate and pH, albuminuria, and mean daytime systolic and diastolic blood pressure.
24 months.
This multicentre study from Switzerland investigated the effect of using sodium bicarbonate to correct metabolic acidosis on the graft function of stable renal transplant recipients. Recipients with a serum bicarbonate level of <22 mmol/L were randomised to oral sodium bicarbonate or placebo for 2 years. Despite adequate correction of metabolic acidosis in the treatment group, there was no difference in eGFR decline between groups, leading the authors to conclude that sodium bicarbonate supplementation to preserve GFR in renal transplant recipients is not recommended.
The methodology of the study is excellent, with centralised variable block randomisation and placebo-control. A modified ITT analysis is used including all patients who were randomised and attended a baseline visit. It should be noted that the mean serum bicarbonate level in both groups at baseline was only just below the lower limit of normal (∼21 mmol/L), leaving the possibility that greater benefit may be seen in patients with a more profound acidosis. However, this was not supported by prespecified subgroup analysis (albeit with more limited statistical power).
5.
mITT.
Yes.
ClinicalTrials.gov—NCT03102996.
Non-Industry.
Heparin Thromboprophylaxis in Simultaneous Pancreas-Kidney Transplantation: A Systematic Review and Meta-Analysis of Observational Studies.
This study aimed to assess the effect of heparin thromboprophylaxis in simultaneous pancreas-kidney (SPK) transplantation, pancreas after kidney (PAK) transplantation and pancreas transplant alone (PTA).
A literature search was performed on PubMed, EMBASE, BIOSIS, MEDLINE, Cochrane Library and Web of Science. Two reviewers independently selected studies for inclusion and extracted the data. Risk of bias was assessed using the Methodological Index for Non-Randomized Studies (MINORS).
11 studies were included in the review.
Outcomes of interest were pancreas thrombosis during early post-transplant period, incidence of postoperative bleeding, pancreas graft loss due to thrombosis, acute return to the operating room, and units of packed red blood cells (pRBC) used.
N/A.
This systematic review and meta-analysis investigated the role of heparin thromboprophylaxis in simultaneous pancreas-kidney (SPK) transplantation, pancreas after kidney (PAK) transplantation and pancreas transplant alone (PTA). Study selection and data extraction were performed in duplicate. Only 11 studies, all of which were retrospective, were included. However, all the included studies were considered high quality (MINORS score > 60%). The authors found that heparin thromboprophylaxis reduced early pancreas thrombosis and pancreas loss by over two-folds for SPK, PAK and PTA, without resulting in an increase in the incidence of bleeding or acute return to the operating room. Heterogeneity was high for some of the outcomes but was not explored. No adjustments for confounders were made in the analyses.
PROSPERO—CRD42021260585.
None.
Graft thrombosis is a recognised and feared complication of pancreas transplantation, resulting from a thromboinflammatory response and relatively low flow through the graft [
In their recent systematic review, Ai Li et al. attempt to summarise the literature regarding heparin thromboprophylaxis following pancreas transplantation [
Whilst the limited amount of observational data published in the literature does appear to support this conclusion overall, there are significant limitations to this study. There is no randomised controlled trial evidence available, and very limited comparative data meaning that the authors resort to comparing single-arm observational data to the control cohorts of other studies. Given the differences in protocols and surgical techniques between centres, the validity of this is uncertain. Even in the four comparative studies, there is significant heterogeneity in treatment protocols and monitoring strategies, meaning that the optimum regimen is unclear.
The authors employ fixed effects methods in some of their meta-analysis. Given the heterogeneous and observational nature of the data, the assumptions of a fixed effects analysis are probably not met. Indeed, re-analysis using a random effects model increases uncertainty and loses the significant treatment effects seen in fixed effects analysis.
It is unlikely that there is enough equipoise to undertake a large RCT of heparin versus no heparin following pancreas transplantation as most centres now use some form of anticoagulation. However, there is scope for future studies to investigate the optimal protocol and monitoring strategy for anticoagulation, including the use of TEG monitoring.
2/5.
The author confirms being the sole contributor of this work and has approved it for publication.
The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.