Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock

NCT00922870 | Completed

• 1 other identifier: 1450
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• the primary outcome will be the number of days without catecholamines at the 28th day of randomization

  28th day

Secondary Outcomes (1)

• 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.

  72h, D90

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

Other: Standard treatment

Cascade

EXPERIMENTAL

Device: Cascade

Interventions

Cascade DEVICE

Cascade treatment over 48h

Cascade

Standard treatment OTHER

Standard therapy

Standard treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Comorbid conditions with an expected survival \< 6 months
• Pregnancy
• Immune compromised patients (e.g. being treated for cancer, treated by immunosuppressors or steroids, AIDS).

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Lundia AB: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (5)

CHU hospital

Clermont-Ferrand, 63003, France

Location

Hopital Le Bocage

Dijon, 21079, France

Location

Centre Hospitalier Marc JACQUET

Melun, 77 000, France

Location

Hopital Tenon

Paris, 75020, France

Location

Hopital Delafontaine

Saint-Denis, 93205, France

Location

MeSH Terms

Conditions

Sepsis

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Monchi Mehran, Dr

  Unaffiliate

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 17, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

FR (5)