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

NCT01077349 | Completed DMC

• 1 other identifier: P071223
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock

Keywords

Cardiac surgery; Shock; Continuous Veno-Venous Haemofiltration; Continuous Renal Replacement Therapy; Renal Insufficiency; Acute

Outcome Measures

Primary Outcomes (1)

• Death from all causes at 30 days after randomisation

  30 days

Secondary Outcomes (5)

• Mortality 60 days following study enrollment

  60 days

• ICU 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

• Hospital mortality

  90 days

Study Arms (2)

high volume hemofiltration

EXPERIMENTAL

Procedure: high volume hemofiltration

standard care

ACTIVE COMPARATOR

Procedure: standard care

Interventions

high volume hemofiltration PROCEDURE

(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).

high volume hemofiltration

standard care PROCEDURE

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

standard care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years
• Pregnancy
• 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 -

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (2)

• Combes A, Brechot N, Amour J, Cozic N, Lebreton G, Guidon C, Zogheib E, Thiranos JC, Rigal JC, Bastien O, Benhaoua H, Abry B, Ouattara A, Trouillet JL, Mallet A, Chastre J, Leprince P, Luyt CE. Early High-Volume Hemofiltration versus Standard Care for Post-Cardiac Surgery Shock. The HEROICS Study. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1179-90. doi: 10.1164/rccm.201503-0516OC.

  PMID: 26167637 RESULT

• Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

  PMID: 36416787 DERIVED

MeSH Terms

Conditions

Shock; Renal Insufficiency

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alain Combes, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 1, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 9, 2017

Record last verified: 2012-10

Locations

FR (1)