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High Volume Veno-venous Hemofiltration Versus Standard Care for Post-cardiac Surgery Shock (HEROICS)

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: February 26, 2010
Last updated: February 8, 2017
Last verified: October 2012
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.

Condition Intervention
Shock Procedure: high volume hemofiltration Procedure: standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Death from all causes at 30 days after randomisation [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Mortality 60 days following study enrollment [ Time Frame: 60 days ]
  • ICU mortality [ Time Frame: 90 days ]
  • Mortality adjusted on the type of surgery and patient severity at randomization [ Time Frame: 90 days ]
  • Mortality 90 days following study enrollment [ Time Frame: 90 days ]
  • Hospital mortality [ Time Frame: 90 days ]

Enrollment: 226
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high volume hemofiltration Procedure: high volume hemofiltration
(80 ml/kg/h or a maximum of 8L/h) for 48 hours following heart surgery. 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 + nor epinephrine/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).
Active Comparator: standard care Procedure: standard care

extra-renal replacement therapy (CVVHDF mode, total effluent <35 ml/kg/h or a maximum of 3500 ml/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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Cardiac surgery with cardiopulmonary bypass
  2. Patient still on high doses catecholamines 3 to 24 hours following cardiac-surgical ICU admission. High doses catecholamines is defined by IV infusion of :

    1. Epinephrine >0.2 microg/kg/min or
    2. Norepinephrine >0.4 microg/kg/min or
    3. Epinephrine + (Norepinephrine /2) >0.2 microg/kg/min
    4. Cardiac assistance using ECMO/ECLS technique are considered equivalent to high doses catecholamines.
  3. 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:

  1. Age < 18 years
  2. Pregnancy
  3. Chronic hemodialysis prior to heart surgery
  4. Body weight >120 kg
  5. Moribund state, defined as SAPS 2 score> 90
  6. Severe underlying disease with survival expectancy of less than 8 days
  7. Decision to withhold or withdraw active therapeutics
  8. PrismaFlex machine unavailable in the unit
  9. Intravascular access with dialysis catheter impossible -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01077349

Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Alain Combes, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01077349     History of Changes
Other Study ID Numbers: P071223
Study First Received: February 26, 2010
Last Updated: February 8, 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cardiac surgery
Continuous Veno-Venous Haemofiltration
Continuous Renal Replacement Therapy
Renal Insufficiency

Additional relevant MeSH terms:
Pathologic Processes processed this record on September 21, 2017