An open pilot study of the efficacy and safety of polygeline in adult subjects with dengue haemorrhagic Fever.

ABSTRACT

Aim: to observe the efficacy and safety of Polygeline colloid (Haemaccel) in adults with stage I - II of dengue haemorrhagic fever (DHF). Methods: an open, non-comparative clinical trial. The subjects were male or female between 17 - 55 years old, who fulfilled the criteria of stage I or II of DHF according to WHO and selected with consecutive sampling. Fluid treatments were given following this protocol polygeline i.v. infusion 500 ml over first 6 hours and continued with 500 ml for the next 18 hours, and maintained to 1000 mL/24 hours from day-2 until maximum day-5. Ringer's lactate infusion 1000 mL/18 hours from the first day to maximum day-5, as maintenance. Efficacy and safety of polygeline colloid were evaluated using initial stabilization of haematocrite level, measured as percentage of clinical trial subject who has stabilization of haemodynamic status based on serial haematocrite levels examinations, total parenteral fluid required and length of hospitalization. Statisticial analysis was done using ANOVA test and post hoc analysis using Turkey test. Results: there were 43 subjects who completely participated in this study and included in analysis. From baseline levels, haematocrite decreased in first 6 hours during fluid treatment. This decrement persisted in 48 hours of observation. Statistical analysis with ANOVA test showed the significant differences of haematocrite level during observation (Sum of square between groups 495 and within group 4845, p= 0.000). Post hoc analysis with Turkey test showed significant differences of haematocrite level from baseline level to 48, 72 and 96 hours during observation periods. Conclusion: this pilot study showed that polygeline colloid was a safe initial fluid treatment and can be used for maintaining fluid adequacy in adults with stage I-II of DHF.