Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gambro Lundia AB
ClinicalTrials.gov Identifier:
NCT00922870
First received: June 15, 2009
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic Shock is associated with an overwhelming, systemic overflow of pro inflammatory and anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ failure, and altered cellular immunological responsiveness. Although our understanding of the complex pathophysiological alterations that occur in septic shock has increased greatly as a result of recent clinical and preclinical studies, mortality associated with the disorder remains unacceptably high, ranging from 30% to 50%. To date, attempts to improve survival with innovative, predominantly anti-inflammatory therapeutic strategies have been disappointing. A standard hemofiltration rate of 35 ml/kg/hour has been successfully used to treat acute renal failure. However, this dose does not alter plasma levels of inflammatory mediators, suggesting that its ability to clear these mediators is suboptimal. Higher doses of hemofiltration (up to 120 ml/kg per hour) have been demonstrated to improve cardiac function and hemodynamics in several animal models of sepsis. High-volume hemofiltration (HVHF) was thus conceived and applied in patients with septic shock, showing an improvements in hemodynamics with decreased vasopressor requirements and improved survival in patients admitted after a cardiac arrest.

The main benefit described with high volume hemofiltration is a hemodynamic improvement (e.g reduction in catecholamines' requirement). This improvement seems to be due to the removal of a badly defined network of middle molecular weight peptides. To remove efficiently these middle molecular peptides, a high filtration rate is needed. However, with high filtration rates, there is also a high clearance for smaller molecules, including antibiotics, electrolytes, vitamins, trace elements and amino acids.

The cascade hemofiltration system has been designed for a more efficient removal of middle molecular weight peptides with a limited solute consumption.

The goal of this study is the evaluation of the hemodynamic improvement using cascade hemofiltration in patients treated for septic shock.


Condition Intervention Phase
Sepsis
Device: Cascade
Other: Standard treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock

Resource links provided by NLM:


Further study details as provided by Gambro Lundia AB:

Primary Outcome Measures:
  • the primary outcome will be the number of days without catecholamines at the 28th day of randomization [ Time Frame: 28th day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of decrease of catecholamines during the first 72h, days without mechanical ventilation at D90, days without RRT for acute renal failure at D90, days without ICU requirement at D90, status at D90. [ Time Frame: 72h, D90 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard treatment Other: Standard treatment
Standard therapy
Experimental: Cascade Device: Cascade
Cascade treatment over 48h

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with a septic shock diagnosed by the medical staff team.
  • Patient mechanically ventilated and treated by high doses of catecholamines after adequate fluid administration (≥ 1.0 mg/h of norepinephrine or epinephrine) for ≥ 120 minutes and < 24h.

Exclusion Criteria:

  • Age (years) < 18 or > 85.
  • Weight >120 kg
  • Thrombocytopenia 50< G/l or Neutrophils <0.5 Giga/l
  • Contra indication to heparin anticoagulation.
  • Patient requiring catecholamines (epinephrine ≥ 1 mg/h or norepinephrine ≥ 1 mg/h) for >24h.
  • Patient admitted to the ICU ≥ 7 days before the inclusion criteria.
  • Comorbid conditions with an expected survival < 6 months
  • Inclusion (<28 days) in another study interfering with the goals of the current investigation.
  • Pregnancy
  • Immune compromised patients (e.g. being treated for cancer, treated by immunosuppressors or steroids, AIDS).
  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 ClinicalTrials.gov identifier: NCT00922870

Locations
France
CHU hospital
Clermont-Ferrand, France, 63003
Hopital Le Bocage
Dijon, France, 21079
Centre Hospitalier Marc JACQUET
Melun, France, 77 000
Hopital Tenon
Paris, France, 75020
Hopital Delafontaine
Saint Denis, France, 93205
Sponsors and Collaborators
Gambro Lundia AB
Investigators
Study Chair: Monchi Mehran, Dr Unaffiliate
  More Information

No publications provided

Responsible Party: Gambro Lundia AB
ClinicalTrials.gov Identifier: NCT00922870     History of Changes
Other Study ID Numbers: 1450
Study First Received: June 15, 2009
Last Updated: April 9, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on July 24, 2014