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

NCT01077349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2017-02-09

No results posted yet for this study

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

Interventions

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).

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alain Combes, MD PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-01-31
Completion
2013-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077349 on ClinicalTrials.gov