The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.
Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study
Open accessAbstract
OBJECTIVE: To determine if intravenous thiamine would reduce lactate in patients with septic shock. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Two US hospitals. PATIENTS: Adult patients with septic shock and elevated (> 3 mmol/L) lactate between 2010 and 2014. INTERVENTIONS: Thiamine 200 mg or matching placebo twice daily for 7 days or until hospital discharge. MEASUREMENTS AND MAIN RESULTS: The primary outcome was lactate levels 24 hours after the first study dose. Of 715 patients meeting the inclusion criteria, 88 patients were enrolled and received study drug. There was no difference in the primary outcome of lactate levels at 24 hours after study start between the thiamine and placebo groups (median: 2.5 mmol/L [1.5, 3.4] vs. 2.6 mmol/L [1.6, 5.1], p = 0.40). There was no difference in secondary outcomes including time to shock reversal, severity of illness and mortality. 35% of the patients were thiamine deficient at baseline. In this predefined subgroup, those in the thiamine treatment group had statistically significantly lower lactate levels at 24 hours (median 2.1 mmol/L [1.4, 2.5] vs. 3.1 [1.9, 8.3], p = 0.03). There was a statistically significant decrease in mortality over time in those receiving thiamine in this subgroup (p = 0.047). CONCLUSION: Administration of thiamine did not improve lactate levels or other outcomes in the overall group of patients with septic shock and elevated lactate. In those with baseline thiamine deficiency, patients in the thiamine group had significantly lower lactate levels at 24 hours and a possible decrease in mortality over time.
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Cites
APACHE II: A severity of disease classification system
KNAUS, W. A., DRAPER, E. A., WAGNER, D. P., & ZIMMERMAN, J. E. (1985) · Critical Care Medicine · doi:10.1097/00003246-198510000-00009 · Cited by 13,664
APACHE II-A Severity of Disease Classification System: Reply
Knaus, W. A., Draper, E. A., Wagner, D. P., & Zimmerman, J. E. (1986) · Critical Care Medicine · doi:10.1097/00003246-198608000-00028 · Cited by 13,376
Vincent, J. L., Moreno, R., Takala, J., Willatts, S., De Mendonça, A., Bruining, H., Reinhart, C. K., Suter, P. M., & Thijs, L. G. (1996) · Intensive Care Medicine · doi:10.1007/bf01709751 · Cited by 11,674
APACHE II: a severity of disease classification system.
Knaus, W. A., Draper, E. S., Wagner, D. P., & Zimmerman, J. E. (1985) · PubMed · Cited by 6,034
A randomized trial of protocol-based care for early septic shock.
The ProCESS Investigators (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1401602 · Cited by 2,414
Goal-Directed Resuscitation for Patients with Early Septic Shock
The ARISE Investigators and the ANZICS Clinical Trials Group (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1404380 · Cited by 2,028
Trial of early, goal-directed resuscitation for septic shock.
Mouncey, P. R., Osborn, T. M., Power, G. S., Harrison, D. A., Sadique, M. Z., Grieve, R. D., Jahan, R., Harvey, S. E., Bell, D., Bion, J. F., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1500896 · Cited by 1,604
Etiology and Therapeutic Approach to Elevated Lactate Levels
Andersen, L. W., Mackenhauer, J., Roberts, J. C., Berg, K. M., Cocchi, M. N., & Donnino, M. W. (2013) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2013.06.012 · Cited by 731
Self-citationPost-randomisation exclusions: the intention to treat principle and excluding patients from analysis
Fergusson, D., Aaron, S. D., Guyatt, G., & Hébert, P. (2002) · BMJ · doi:10.1136/bmj.325.7365.652 · Cited by 708 · cited 1×
“analysis was based on a modified intention to treat principle where all patients who received at least one dose of the study drug were included.(26) For the 24 hour time point, lactate levels were imputed based on a pre-defined plan in patients who died before this time point.”
MethodCasserly, B., Phillips, G. S., Schorr, C., Dellinger, R. P., Townsend, S. R., Osborn, T. M., Reinhart, K., Selvakumar, N., & Levy, M. M. (2015) · Critical Care Medicine · doi:10.1097/ccm.0000000000000742 · Cited by 465
Cited by
Weiss, S. L., Peters, M. J., Alhazzani, W., Agus, M. S. D., Flori, H. R., Inwald, D. P., Nadel, S., Schlapbach, L. J., Tasker, R. C., Argent, A. C., et al. (2020) · Pediatric Critical Care Medicine · doi:10.1097/pcc.0000000000002198 · Cited by 1,228
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock
Marik, P. E., Khangoora, V., Rivera, R., Hooper, M. H., & Catravas, J. (2017) · Chest · doi:10.1016/j.chest.2016.11.036 · Cited by 887
Weiss, S. L., Peters, M. J., Alhazzani, W., Agus, M. S. D., Flori, H. R., Inwald, D. P., Nadel, S., Schlapbach, L. J., Tasker, R. C., Argent, A. C., et al. (2020) · Intensive Care Medicine · doi:10.1007/s00134-019-05878-6 · Cited by 606
Fujii, T., Luethi, N., Young, P. J., Frei, D. R., Eastwood, G. M., French, C. J., Deane, A. M., Shehabi, Y., Hajjar, L. A., Oliveira, G., et al. (2020) · JAMA · doi:10.1001/jama.2019.22176 · Cited by 466
Thiamine deficiency disorders: Diagnosis, prevalence, and a roadmap for global control programs
Whitfield, K. C., Bourassa, M. W., Adamolekun, B., Bergeron, G., Bettendorff, L., Brown, K. H., Cox, L., Fattal‐Valevski, A., Fischer, P. R., Frank, E. L., et al. (2018) · Annals of the New York Academy of Sciences · doi:10.1111/nyas.13919 · Cited by 336
Metadata
- Authors
- Donnino, M. W., Andersen, L. W., Chase, M., Berg, K. M., Tidswell, M., Giberson, T., Wolfe, R., Moskowitz, A., Smithline, H., Ngo, L., & Cocchi, M. N.
- Venue
- Critical Care Medicine
- Published
- 2016-02
- Volume
- 44
- Issue
- 2
- Pages
- 360-367
- ISSN
- 0090-3493 (ISSN-L)
- OpenAlex
- W2241408506
- Cited by
- 293
- References
- 32
- FWCI
- 23.99
- Type
- journal article
- Language
- en
- Open access
- green
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- Donnino, M. W., Andersen, L. W., Chase, M., Berg, K. M., Tidswell, M., Giberson, T., Wolfe, R., Moskowitz, A., Smithline, H., Ngo, L., & Cocchi, M. N. (2016). Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Critical Care Medicine. https://doi.org/10.1097/ccm.0000000000001572
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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