A prospective randomized trial evaluating colloid versus crystalloid resuscitation in the treatment of the vascular leak syndrome associated with interleukin-2 therapy

Summary: Interleukin-2 (IL-2)-based therapy induces a vascular leak syndrome (VLS), manifested by hypotension, tachycardia, and oliguria, as is also seen with septic shock. The optimal method for trating such VLS is not known. A prospective randomized to receive crystalloid (0.9% normal saline) or colloid (5% human serum albumin) fluid boluses to maintain acceptable vital sugns and urine output. Patients refractory to fluid boluses were givern dopamine for oliguria and/or phenlylephrine for hypotension. Of 107 patients who completed one cycle of therapy on sltudy, 76 completed a full tratment course (two cycles) on study. The total number of saline and albumin fluid boluses given were 9.5 ± 0.9 versus 7.7 ± 0.7 (p = 0.36, n = 107) for the first cycle and 19.2 ± 1.8 versus 16.1 ± 1.6 (p = 0.33, n - 76) for a complete course, respectively. Although patients receiving saline boluses had significantlyn more oliguria during a course of therapy, weight gain, number of IL-2 doses, tachycarcia, hypotension, vasopressor use, hospital stay, and clinical response rates did not significantly differ between arms. Changes in hematocrit, hemoglobin, protein, albumin, blood urea nitrogen (BUN), and creatinine were analyzed, and patients receiving crystalloid showed greater decrases in albumin (p < 0.0001) and total protein (p < 0.05) as expected. A 40-fold greater cost associated with albumin suggested that crystalloid resuscitation be used to treat the VLS associated with IL-2 therapy.