Lactic acidosis is a relatively common metabolic disorder having a high mortality. Conventional therapy consists principally of alkali administration which may be effective in some cases but may worsen acidemia and cardiac function in others. We propose a prospective, double-blind, placebo-controlled study to assess the efficacy of sodium dichloroacetate (DCA) in treating lactic acidosis. Animal studies have demonstrated that DCA is effective in preventing or reversing lactic acidosis induced by various experimental means. Preliminary studies in humans attest to the general safety and effectiveness of the treatment schedule we propose. Eight clinical centers will participate in the study. The patient population will consist of adult subjects without insulin-dependent diabetes who have a blood lactate equal 5 mEq/1 and arterial pH less than 7.35. Once entered into the study, patients will be randomized to receive either DCA (two or more doses at 50 mg/kd/dose) or placebo (saline) by infusion. Patients in either group with an arterial pH less than 7. will also receive NaHCO3. Multiple chemical and hemodynamic indices will be evaluated, including blood lactate, blood gases, electrolytes and cardiac index. Absolute survival, survival time and amount of NaHCO3 will also be tabulated. The computer and biostatistics services of the George Washington University Biostatistics Unit will be employed for data monitoring and analysis. An advisory committee, whose members are privy to the treatment code but are not involved in patient recruitment or care, will conduct periodic reviews of the study. The Study Chairman, together with the Steering and Planning Committee will have overall responsibility for the conduct of the study.
| Henderson, G N; Curry, S H; Derendorf, H et al. (1997) Pharmacokinetics of dichloroacetate in adult patients with lactic acidosis. J Clin Pharmacol 37:416-25 |
| Stacpoole, P W; Wright, E C; Baumgartner, T G et al. (1994) Natural history and course of acquired lactic acidosis in adults. DCA-Lactic Acidosis Study Group. Am J Med 97:47-54 |
| Stacpoole, P W (1993) Lactic acidosis. Endocrinol Metab Clin North Am 22:221-45 |
