Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01077349
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : February 9, 2017
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Shock Procedure: high volume hemofiltration Procedure: standard care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
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
Study Start Date : December 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery Shock

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01077349

Layout table for location information
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Layout table for investigator information
Principal Investigator: Alain Combes, MD PhD Assistance Publique - Hôpitaux de Paris
Publications of Results:
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01077349    
Other Study ID Numbers: P071223
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: October 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cardiac surgery
Continuous Veno-Venous Haemofiltration
Continuous Renal Replacement Therapy
Renal Insufficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes