Plasma exchange for lung haemorrhages in leptospirosis

INTERVENTION: ‐ Study setting: Medical wards, emergency care unit and intensive care units of the Teaching Hospital, Karapitiya ‐ Randomisation: patients will be allocated to two arms using the Block randomization (Blocks of two) method. ‐ Intervention: A femoral line will be inserted for vascular access and Acid Citrate Dextrose (ACD) will be used as the anticoagulant of choice. ACD to whole blood ratio of 1:12 to 1: 14 will be maintained. The speed set for blood pump will be 50 ml per minute initially as most of these patients are hypotensive and on inotropes and then gradually increased to 80 ml depending on the patient’s haemodynamic stability. Return speed will also be kept at 80 ml/min to prevent entering of high citrate load rapidly. Patient’s height, weight and haemotocrit will be entered to machine and the machine automatically calculates the patient’s blood volume and plasma volume. One plasma volume will be exchanged with Fresh Frozen Plasma (FFP). Percentage of replacement will be kept around 90 – 95% as most of these patients have acute kidney injury with low urine output. Mean number of cycles are three and done on three consecutive days. ‐ Blinding ‐ This is an open‐labeled study. CONDITION: Leptospirosis PRIMARY OUTCOME: Overall survival SECONDARY OUTCOME: ‐ Duration of the ICU stay and hospital stay, ; ‐ Need of ventilatory support ; ‐ Need of inotrophs to support blood pressure, ; ‐ Use of antiarrhythmic agents ; ‐ Use of renal replacement therapy ; ‐ Use of liver failure therapy ; ‐ Incidence of sepsis ; ‐ Incidence of pneumonia ; ‐ Incidence of line infection spontaneous bleeding ; INCLUSION CRITERIA: ‐ Age 15 to 80 , with lung hemorrhages due to leptospirosis. Diagnosis of leptospirosis: Patients with a clinical picture suggestive of leptospirosis and confirmed with PCR, MAT or both) Definition of leptospirosis associated pulmonary hemorrhage: Patient with confirmed leptospirosis presenting with haemoptysis, arterial hypoxemia (Acute Lung Score < 2.5), haemoglobin drop (>10% from the previous value), or diffused alveolar shadows in the chest radiograph. The above manifestations should not have an alternative explanation.