Clinical Impact of Hemoperfusion With a Neutral Macroporous Resin Cartridge as Adjunctive Treatment in Septic Patients With Multiorgan Dysfunction Syndrome (MODS) Admitted to Intensive Care Units.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemoperfusion
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- IL-6 plasmatic concentration
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:
- •Sepsis of abdominal origin with controlled infectious focus.
- •Noradrenaline dose\> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.
- •Dysfunction of two or more organs with SOFA ≥ 9 (5).
- •Blood lactate ≥ 2 mmol / L.
- •Procalcitonin (PCT)\> 10 ng / mL.
- •CRP\> 100 mg / L.
- •IL-6\> 2000 pg / ml.
Exclusion Criteria
- •Age under 18 years or over 80 years.
- •Pregnancy or breastfeeding.
- •Terminally ill patients or with a life expectancy of less than 48 hours.
- •Thrombocytopenia \<60,000 / mm
- •Pancytopenia.
- •Severe coagulopathy with high risk of bleeding.
- •Inclusion in another research protocol.
- •In case of re-entry during the study period, only the first admission will be included.
- •Use of another haemoperfusion device.
Outcomes
Primary Outcomes
IL-6 plasmatic concentration
Time Frame: During hemoperfusion
Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process
Adverse events
Time Frame: During hemoperfusion
Analyze the presence of adverse events during the hemoperfusion process
Organ failure
Time Frame: During hemoperfusion
Analyze the number and severity of failed organs during the hemoperfusion process
Vasopressors dose
Time Frame: During ICU stay
Analyze the number of days on vasopressor support during ICU stay
Mean arterial pressure
Time Frame: During hemoperfusion
Analyze the patient's variation of mean arterial pressure during hemoperfusion
Mechanical ventilation
Time Frame: During ICU stay
Analyze the number of days on mechanical ventilation during ICU stay
Renal replacement therapy
Time Frame: During ICU stay
Analyze the number of days on renal replacement therapy during ICU stay
ICU length of stay
Time Frame: Post-Intensive Care Unit discharge
Analyze the patient's length of stay in ICU
ICU survival
Time Frame: Post-Intensive Care Unit discharge
Analyze the patient's survival in ICU
Hospital stay
Time Frame: post-hospital discharge
Analyze the patient's length of stay post-Intensive Care Unit discharge
Hospital survival
Time Frame: Post-hospital discharge
Analyze the patient's survival post-hospital discharge