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

This study is currently recruiting participants.
Verified October 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01077349
First received: February 26, 2010
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Phase
Shock
 Procedure: high volume hemofiltration
Procedure: standard care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Heart Surgery Shock
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 330
Study Start Date: December 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (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).
Other Name: high volume hemofiltration
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
Other Name: standard care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077349

Contacts
Contact: Alain COMBES, MD phD +33142163818 alain.combes@psl.aphp.fr

Locations
France
Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Alain Combes, MD PhD     +33142163818     alain.combes@psl.aphp.fr    
Principal Investigator: Alain Combes, MD PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alain Combes, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01077349     History of Changes
Other Study ID Numbers: P071223
Study First Received: February 26, 2010
Last Updated: October 30, 2012
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013