Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock

NCT ID: NCT00922870

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard treatment

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: OTHER

Standard therapy

Cascade

Group Type: EXPERIMENTAL

Cascade

Intervention Type: DEVICE

Cascade treatment over 48h

Interventions

Cascade

Cascade treatment over 48h

Intervention Type: DEVICE

Standard treatment

Standard therapy

Intervention Type: OTHER

Eligibility 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.

• 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).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gambro Lundia AB

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monchi Mehran, Dr

Role: STUDY_CHAIR

Unaffiliate

Locations

CHU hospital

Clermont-Ferrand, , France

Hopital Le Bocage

Dijon, , France

Centre Hospitalier Marc JACQUET

Melun, , France

Hopital Tenon

Paris, , France

Hopital Delafontaine

Saint-Denis, , France

Countries

France

Other Identifiers

1450

Identifier Type: -

Identifier Source: org_study_id