Efficacy of human atrial natriuretic peptide for the patients with severe sepsis; Impact on prevention against acute kidney injury

INTERVENTION: The patients with severe sepsis are treated following Surviving Sepsis Campaign guidelines 2008. Patients are randomly assigned to receive hANP or distilled water (placebo) for continuous infusion. HANP is started if catecholamine index is lower than 50 and mean arterial pressure keeps more than 65 mmHg without vasopressin. HANP is administered 1000‐4000 mcg per day as much as possible. In addition, hANP is administered until patients are discharged from ICU or for 14 days in ICU stay. Administration of hANP will be stopped when the adverse event is seen as follows; severe hypotension, drug allergy, anaphylaxis, severe organ failure and so on due to hANP. Severe hypotension is defined as mean arterial pressure will be less than 65mmHg and simultaneously re‐administration of vasopressin will be considered. (Catecholamine index; Dopamine (mcg/kg/min) + Dobutamine (mcg/kg/min) + Noradrenaline (mcg/kg/min) * 100) The patients with severe sepsis are treated following Surviving Sepsis Campaign guidelines 2008. Distilled water (placebo) is started if catecholamine index is lower than 50 and mean arterial pressure keeps more than 65 mmHg without vasopressin. In addition, distilled water is administered until patients are discharged from ICU or for 14 days in ICU stay. (Catecholamine index; Dopamine (mcg/kg/min) + Dobutamine (mcg/kg/min) + Noradrenaline (mcg/kg/min) * 100) CONDITION: Severe sepsis PRIMARY OUTCOME: 30‐day mortality SECONDARY OUTCOME: Renal function ; Introduction of maintenance haemodialysis (HD); Ventilator free days; 90‐day mortality INCLUSION CRITERIA: The eligibility criteria for the study are age older 16 years and the presence of severe sepsis or septic shock. Patients, who have renal failure according to RIFLE category or are dependent on mechanical ventilation including non‐invasive ventilation, are enrolled. All patients are needed to have written informed consent before enrolment in the study.