OBJECTIVE: We studied the ability of carbazochrome sodium sulfonate (AC-17) to prevent capillary permeability in dengue hemorrhagic fever/dengue shock syndrome. METHOD: A randomized, placebo-controlled trial in 95 children stratified by age and sex was conducted in two hospitals during 1992. AC-17 (n = 45 cases) or B vitamins as placebo (n = 50) were given as a bolus infusion and then as a continuous drip for 24 hours; a total of 300 mg of AC-17 was administered on the first 2 days and 150 mg on the third day. RESULTS: The two groups were comparable in age, sex, duration of illness, and clinical manifestations. No significant difference in shock or pleural effusion was noted between the two groups. Shock developed in 8.9% (4/45) of patients in the AC-17 group and 6% (3/50) in the placebo group (p = 0.44). Pleural effusion was found at 0, 24, 48, and 72 hours after admission in 4.4%, 20%, 31.1%, and 20% in the AC-17 group and 2%, 14%, 28%, and 14% in the placebo group, respectively. CONCLUSION: Administration of AC-17 does not prevent plasma leakage or shock in dengue hemorrhagic fever/dengue shock syndrome.
RCT Entities:
OBJECTIVE: We studied the ability of carbazochrome sodium sulfonate (AC-17) to prevent capillary permeability in dengue hemorrhagic fever/dengue shock syndrome. METHOD: A randomized, placebo-controlled trial in 95 children stratified by age and sex was conducted in two hospitals during 1992. AC-17 (n = 45 cases) or B vitamins as placebo (n = 50) were given as a bolus infusion and then as a continuous drip for 24 hours; a total of 300 mg of AC-17 was administered on the first 2 days and 150 mg on the third day. RESULTS: The two groups were comparable in age, sex, duration of illness, and clinical manifestations. No significant difference in shock or pleural effusion was noted between the two groups. Shock developed in 8.9% (4/45) of patients in the AC-17 group and 6% (3/50) in the placebo group (p = 0.44). Pleural effusion was found at 0, 24, 48, and 72 hours after admission in 4.4%, 20%, 31.1%, and 20% in the AC-17 group and 2%, 14%, 28%, and 14% in the placebo group, respectively. CONCLUSION: Administration of AC-17 does not prevent plasma leakage or shock in dengue hemorrhagic fever/dengue shock syndrome.