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. 2025 Apr 3:4:1564460.
doi: 10.3389/frtra.2025.1564460. eCollection 2025.

Donor's therapeutic hypothermia vs. normothermia in kidney transplantation: a meta-analysis of randomized controlled trials

Luccas Marcolin Miranda  1 , Pedro Emanuel Carneiro De Lima  2 , Nathalia De Carvalho Dias Miranda  3 , Giovanna Zaniolo Margraf  1 , Juliano Riella  4
Affiliations

Donor's therapeutic hypothermia vs. normothermia in kidney transplantation: a meta-analysis of randomized controlled trials

Luccas Marcolin Miranda et al. Front Transplant. .

Abstract

Introduction: The shortage of organs remains one of the most challenging global problems nowadays. Donor's therapeutic hypothermia was suggested to decrease kidney delayed graft function (DGF) when compared to normothermia in previous trials, but the role of such intervention is still controversial. To assess this, we performed a systematic review and meta-analysis of randomized clinical trials (RCTs) investigating the benefits of donor hypothermia in DGF rate and Graft Failure.

Methods: MEDLINE, Embase, and Cochrane databases were systematically searched for studies of deceased organ donors who underwent hypothermia or normothermia prior to kidney transplantation. Statistical analysis was performed using R Studio version 3.6. Heterogeneity was assessed using I 2 statistics and a Baujat Plot.

Results: Four different RCTs were analyzed, including more than 3,000 recipients. Donor hypothermia was associated with a lower, but not statistically significant, rate of DGF (RR 0.87; 95% CI 0.71-1.08; P = .21) and graft failure (RR 0.70; 95% CI 0.45-1.10; P = .12). When analyzing only expanded criteria donors, a significantly lower rate of DGF was observed in the hypothermia-treated group (RR 0.65; 95% CI 0.47-0.89; P = .008). Sensitivity analysis identified one study as an outlier, probably due to protocol deviation. When excluded from the analysis, a significant reduction in DGF rate was observed among the hypothermia-treated group (RR 0.80; 95% CI 0.67-0.94; P = .007).

Conclusion: Our meta-analysis could not find a statistical difference between donor therapeutic hypothermia and normothermia in preventing DGF or Graft Failure. However, these results may be influenced by outliers and the limitations of the included studies. Further research is needed to clarify the role of donor hypothermia in kidney transplantation. If proven beneficial, it could be a promising alternative to sites where preservation techniques are limited, such as low-income countries.

Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024581665, PROSPERO (CRD42024581665).

Keywords: delayed graft function; graft failure; graft survival; hypothermia; kidney transplantation.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Study selection flow diagram.
Figure 2
Figure 2
Delayed graft function with donor's therapeutic hypothermia vs. normothermia stratified by subgroup analysis involving the adjunctive use of machine perfusion. 1Around 10% of the kidneys in the HYPOREME trial were not submitted to machine perfusion, being a significant proportion due to severe atherosclerotic disease or unfavorable anatomy. Since these factors are already associated with poorer DGF outcomes and the subdivision of the trial's population would distort sample size calculation, the HYPOREME trial was analyzed in an intention-to-treat manner concerning the use of machine perfusion.
Figure 3
Figure 3
Delayed graft function with donor's therapeutic hypothermia vs. normothermia including only extended criteria donors.
Figure 4
Figure 4
Graft-Failure with donor's therapeutic hypothermia vs. normothermia.
Figure 5
Figure 5
Delayed graft function with donor's therapeutic hypothermia vs. normothermia excluding Malinoski et al. (2023) (10).
See this image and copyright information in PMC

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