Polygeline in hypovolemia due to traumatic injury: Results of an open label study in Indian population

Abstract

Objective:

Evaluation of efficacy and safety of polygeline in adult patients with hypovolemia.

Materials and Methods:

In an open label, non-comparative study intravenous infusion of polygeline was administered to adult patients with hypovolemia following traumatic injury. Efficacy was evaluated by noting changes in the signs and symptoms of hypovolemia while safety was evaluated by recording adverse events.

Results:

Forty nine patients with mean age 33.67 ± 15.36 years having long bones fracture were enrolled. The mean and percentage of blood loss was 1291.30 ± 168.43 ml and 26.09 ± 3.13% respectively. Polygeline was given to all patients while other intravenous fluids were required in 44 patients. Baseline heart rate reduced from 100.09 ± 9.13 per minute to 98.45 ± 12.60 and 86 ± 10.10 at one hour ( P < 0.05) and at two hours ( P < 0.001) respectively. The reduction in heart rate was significant at other time points (<0.001) too. Systolic blood pressure (BP) increased from 79.06 ± 10.22 to 94.27 ± 9.18 mm Hg at one hour and 109.18 ± 6.80 mm Hg at two hours (both one and two hours; P < 0.001). Similarly diastolic BP also increased from 57.79 ± 10.59 to 62.89 ± 9.62 mm Hg at one hour and 69.41 ± 11.59 mm Hg at two hours (both one and two hours; P < 0.001). Rise in blood pressure was consistent till 24 hours. Overall improvement was seen in 97.92% patients. Improvement in pallor, dry tongue, and skin changes six and 24 hours was observed in 77.08%, 79.17%, 59.57% and 87.50%, 100% and 93.62% patients respectively (all parameters at six and 24 hours P < 0.0001). No patient reported adverse event.

Conclusion:

Polygeline is safe and effective treatment for correcting hemodynamic instability in hypovolemia due to trauma. Use of polygeline resulted in early and significant improvement in hemodynamic parameters.