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. 2023 Nov 7;24(1):330.
doi: 10.1186/s12882-023-03347-3.

Performance of synacthen test in chronic hemodialysis patients

Affiliations

Performance of synacthen test in chronic hemodialysis patients

Manuela Nickler et al. BMC Nephrol. .

Abstract

Background: Adrenal function tests (Synacthen test) in chronic hemodialysis (HD) patients are currently performed off dialysis. The study aimed to demonstrate equivalence of serum cortisol concentrations pre- and during HD, each for standard-dose (250 µg) and low-dose (1 µg) Synacthen test.

Methods: In a single-center cross-over diagnostic equivalence study, Synacthen tests were performed in four settings, in standard- and low-dose as well as pre- and during HD. Serum cortisol concentration was measured at 30 and 60 min after Synacthen administration, and additionally at 20 min in low dose test. Based on a multivariable linear mixed model the means of cortisol concentration on log-scale were estimated in each dose and test time combination. Differences in means were calculated and the TOST approach was applied to test for equivalence. Equivalence was proven if the 90% confidence interval of the difference of two cortisol means was entirely between - 0.22 and 0.22.

Results: In 28 chronic HD patients, serum cortisol concentrations at 30 and 60 min after Synacthen administration in both standard- and low-dose were shown to be equivalent pre- and during HD. In 10 of 56 low-dose tests, the cortisol peak was already reached after 20 min. However, cortisol concentrations at 20 and 30 min after low-dose Synacthen test pre- and during HD showed no significant difference.

Conclusion: These results suggest that the adrenal function test may be carried out during an ongoing HD session, leading to a more patient-friendly performance of the test, less organizational effort and potentially earlier diagnosis of adrenal insufficiency.

Keywords: Adrenal insufficiency; Cortisol; Equivalence; Hemodialysis; Synacthen test.

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Conflict of interest statement

StS receives advisory benefits from Peripal and Versantis. All other authors declare that they have no competing interests associated with this manuscript.

Figures

Fig. 1
Fig. 1
Cortisol concentrations of 28 study participants in the four different settings of Synacthen dose (low-dose (1 µg) and standard-dose (250 µg)) and administration (pre- and during HD. Abbreviation: HD – hemodialysis
Fig. 2
Fig. 2
Differences of means of estimated cortisol concentration (nmol/l) on log scale and corresponding 90%–confidence intervals (CI) in each dose and administration time combination at 30 and 60 min after Synacthen. Abbreviation: CI – confidence interval, HD – hemodialysis. The equivalence region is shown by vertical dotted lines. All 90%-CI are entirely included in the equivalence region, equivalence for all settings has been proven
Fig. 3
Fig. 3
Cortisol concentration (nmol/l) after low-dose Synacthen administration pre- and during HD in the 28 study participants. Abbreviation: HD – hemodialysis
Fig. 4
Fig. 4
Changes in serum cortisol concentration during HD without Synacthen (A) and estimated smooth effects for HD time on serum cortisol concentration (nmol/l) on log-scale from a multivariable linear additive mixed model (B). Abbreviation: HD – hemodialysis. The random intercept has accounted for multiple cortisol measurements during HD for each subject and HD time was modelled using restricted cubic splines

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