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Randomized Controlled Trial
. 2023 Sep 1;208(5):570-578.
doi: 10.1164/rccm.202301-0034OC.

Thiamine for Renal Protection in Septic Shock (TRPSS): A Randomized, Placebo-controlled, Clinical Trial

Ari Moskowitz  1   2   3 , Katherine M Berg  3   4 , Anne V Grossestreuer  3   5 , Lakshman Balaji  3   5 , Xiaowen Liu  3 , Michael N Cocchi  3   5 , Maureen Chase  3   5 , Michelle Ng Gong  1   2 , Jonathan Gong  6 , Samir M Parikh  7 , Long Ngo  8 , Noa Berlin  3 , Michael W Donnino  3   4   5
Affiliations
Randomized Controlled Trial

Thiamine for Renal Protection in Septic Shock (TRPSS): A Randomized, Placebo-controlled, Clinical Trial

Ari Moskowitz et al. Am J Respir Crit Care Med. .

Abstract

Rationale: Kidney injury is common and associated with worse outcomes in patients with septic shock. Mitochondrial resuscitation with thiamine (vitamin B1) may attenuate septic kidney injury. Objectives: To assess whether thiamine supplementation attenuates kidney injury in septic shock. Methods: The TRPSS (Thiamine for Renal Protection in Septic Shock) trial was a multicenter, randomized, placebo-controlled trial of thiamine versus placebo in septic shock. The primary outcome was change in serum creatinine between enrollment and 72 hours after enrollment. Measurements and Main Results: Eighty-eight patients were enrolled (42 patients received the intervention, and 46 received placebo). There was no significant between-groups difference in creatinine at 72 hours (mean difference, -0.57 mg/dl; 95% confidence interval, -1.18, 0.04; P = 0.07). There was no difference in receipt of kidney replacement therapy (14.3% vs. 21.7%, P = 0.34), acute kidney injury (as defined by stage 3 of the Kidney Disease: Improving Global Outcomes acute kidney injury scale; 54.7% vs. 73.9%, P = 0.07), or mortality (35.7% vs. 54.3%, P = 0.14) between the thiamine and placebo groups. Patients who received thiamine had more ICU-free days (median [interquartile range]: 22.5 [0.0-25.0] vs. 0.0 [0.0-23.0], P < 0.01). In the thiamine-deficient cohort (27.4% of patients), there was no difference in rates of kidney failure (57.1% thiamine vs. 81.5% placebo) or in-hospital mortality (28.6% vs. 68.8%) between groups. Conclusions: In the TRPSS trial, there was no statistically significant difference in the primary outcome of change in creatinine over time. Patients who received thiamine had more ICU-free days, but there was no difference in other secondary outcomes. Clinical trial registered with www.clinicaltrials.gov (NCT03550794).

Keywords: kidney injury; sepsis; shock; thiamine.

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Figures

Figure 1.
Figure 1.
Cohort selection (CONSORT diagram). COVID-19 = coronavirus disease.
Figure 2.
Figure 2.
Longitudinal plot of serum creatinine by group over time. Error bars represent 95% CI. CI = confidence interval.
Figure 3.
Figure 3.
All-cause mortality to hospital discharge by group.
See this image and copyright information in PMC

Comment in

References

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