Extracorporeal Cytokine Removal in Patients With Septic Shock in an Adult Intensive Care Unit

NCT04231695 | Unknown

• 1 other identifier: Cytokine
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Goals Primary: compare changes in norepinephrine requirements before and after hemoperfusion (HP) treatment. Secondary: demonstrate the decrease in levels of IL-6 , assess the total and individual change of SEQUENTIAL ORGAN FAILURE ASSESSMENT (SOFA), establish the resolution of shock , clearance of lactate , and mortality at discharge from INTENSIVE CARE UNIT (ICU), at 30 and 60 days.

Conditions

Septic Shock

Keywords

septic shock; MODS; hemoperfusion; CRRT; ECMO

Outcome Measures

Primary Outcomes (1)

• changes in norepinephrine requirements meassured in micrograms/kg/ min ( gamma) before and after hemoperfusion (HP) treatment.

  we will meassure norepinephrine requirements by placing arterial monitoring during hemoperfusion procedure

  8 hours

Secondary Outcomes (4)

• levels of IL-6

  8 hours

• changes of Sequential Organ Failure Assessment ( SOFA)

  8 hours

• concentration of lactate clearence

  8 hours

• mortality at discharge from UTI

  7 days; 30 days , 60 days

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An observational study will be carried out in adult patients with septic shock (according to the definition of Sepsis-3), presenting hypotension, requiring vasopressors to maintain a mean arterial pressure (MAP) of 65 mmHg, blood lactate\> 2 mmol / L, after adequate fluid resuscitation and in need of extracorporeal membrane oxygenation (Extracorporeal Membrane Oxygenation, ECMO), Renal Replacement Therapy (TRR) (which may be continuous (Continuous Renal Replacement Therapy (CRRT)) or Extended Slow Daily Dialysis ( Slow Extended Dialy Dialysis (SLEDD)) or both, added to the hemoperfusion (HP) treatment.

You may qualify if:

• \> 18 years 2. Diagnosis of septic shock (according to sepsis-3 definition) 3. Dose of norepinephrine ≧ 0.4 μg / kg / min 4. Plasma levels of IL-6\> 900 pg / mL 5. Procalcitonin (PCT) ≧ 2 ng / mL 6. Need for renal replacement therapies or ECMO

You may not qualify if:

• Neoplastic disease with or without treatment
• Pregnant or lactating women (human chorionic gonadotrophin (hCG) test will be performed on potential patients before recruiting for treatment) -

Sponsors & Collaborators

• Hospital Jose Maria Cullen: lead

Study Sites (1)

Hospital Dr Jose Maria Cullen

Santa Fe, 3000, Argentina

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rafael Avila, MD

CONTACT

+5493425012511; rafadata1@hotmail.com

Maria Filippi, MD

CONTACT

+5493425290054

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rafael Avila ( PI)

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 18, 2020
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

AR (1)