Early Continuous High Volume Veno-venous Hemofiltration vs. Standard Care for Post-cardiac Surgery Shock Requiring High Doses Catecholamines. The HEROICS Study: HEmofiltration to Rescue Severe shOck followIng Cardiac Surgery

Study Title - Early continuous high volume veno-venous hemofiltration vs. standard care for post-cardiac surgery shock requiring high dose catecholamines. An open label randomized multicenter controlled trial. The HEROICS Study: HEmofiltration to Rescue severe shOck followIng Cardiac Surgery.

Clinical Phase - III Study Rationale - Systemic inflammatory response syndrome associated with cardiac surgery under cardiopulmonary bypass (CPB) shares many pathophysiologic features of septic shock and post-resuscitation syndrome. Since high volume hemofiltration has been shown to markedly improve hemodynamic profile and survival in these situations, there is a strong rationale for testing, with an adequately powered randomized controlled trial, this purification technique in patients developing post-cardiac surgery shock requiring high doses catecholamine.

Trial Design -

The proposed study will compare high volume hemofiltration (80 ml/kg/h or a maximum of 8L/h) for 48 hours following heart surgery to standard treatment, where extra-renal replacement therapy (CVVHDF mode, total effluent <35 ml/kg/h) will be initiated only if the following criteria are met:

• Serum creatinine > 350 micromol/L or increase x3.0 from pre-operative value OR
• Diuresis < 0.3 ml/kg/h for 24 hours despite adequate fluid resuscitation OR
• Or serum urea > 36 mmol/l OR
• Or life threatening hyperkalemia. In the experimental arm, hemofiltration will be stopped after 48h if diuresis >1500 ml without diuretics and if IV infusion of catecholamines is less than 0.1 microg/kg/min of epinephrine, 0.2 microg/kg/min of norepinephrine or the sum of epinephrine + norepinephrine/2 is less than 0.1 microg/kg/min. In other cases, hemodiafiltration (CVVHDF) will be initiated until the above objectives are reached, with equal flow rate of dialysate and reinfusion fluid, the sum of which being 35 ml/kg/h (or a maximum of 3500 ml/h).