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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 226
- Locations
- 2
- Primary Endpoint
- Death from all causes at 30 days after randomisation
Study Overview
Brief Summary
This study seeks to determine if early continuous High Volume Veno-venous Hemofiltration (HVHF) reduces 30-day all cause mortality in post-cardiac surgery patients developing shock requiring high doses catecholamines.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cardiac surgery with cardiopulmonary bypass
- •Patient still on high doses catecholamines 3 to 24 hours following cardiac-surgical ICU admission. High doses catecholamines is defined by IV infusion of :
- •Epinephrine >0.2 microg/kg/min or
- •Norepinephrine >0.4 microg/kg/min or
- •Epinephrine + (Norepinephrine /2) >0.2 microg/kg/min
- •Cardiac assistance using ECMO/ECLS technique are considered equivalent to high doses catecholamines.
- •Informed consent has been obtained from next of kin or when consent cannot be obtained, the intervention is randomized, and written informed consent obtained from the patient as soon as he regains consciousness. This practice is consistent with the French law for clinical research.
Exclusion Criteria
- •Age < 18 years
- •Chronic hemodialysis prior to heart surgery
- •Body weight >120 kg
- •Moribund state, defined as SAPS 2 score> 90
- •Severe underlying disease with survival expectancy of less than 8 days
- •Decision to withhold or withdraw active therapeutics
- •PrismaFlex machine unavailable in the unit
- •Intravascular access with dialysis catheter impossible -
Outcomes
Primary Outcomes
Death from all causes at 30 days after randomisation
Time Frame: 30 days
Secondary Outcomes
- ICU mortality(90 days)
- Mortality 60 days following study enrollment(60 days)
- Hospital mortality(90 days)
- Mortality adjusted on the type of surgery and patient severity at randomization(90 days)
- Mortality 90 days following study enrollment(90 days)