Hemadsorption through supportive establishment of an Oxiris® filter in septic shock with suspected cytokine release syndrome - a randomized controlled intervention study

Not Applicable

Completed

• Conditions: Septic shock; R57.2

• Registration Number: DRKS00027287
• Lead Sponsor: Klinik für Anästhesiologie Universitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-24
• Study Completion: 2023-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Written declaration of consent by the study participant or his legally appointed representative
- Age = 18 years
- Suspected infection
- Furthermore, the criteria of septic shock according to the sepsis 3 definition must be met:
- Suspected infection (see above)
- SOFA score = 2
- Vasopressor requirement to maintain adequate hemodynamics (MAP = 65 mmHg), despite sufficient fluid resuscitation
- Serum lactate > 2 mmol / l

- In addition, there must be suspicion of a cytokine release syndrome, determined with a Point of Care IL-6 test (Milena® Quick Line IL-6 test). Defined as:
IL -6 > 300 pg / ml

- Furthermore, indications for a renal replacement therapy (RRT) must be met, according to the following absolute or relative criteria:
Absolute criteria: Critical ill patient and one of the following:
- Blood urea nitrogen > 200 mg/dl
- Potassium > 5.8 mmol/l
- urine excretion < 0.3 ml/kg/h > 6 hrs and refractary pulmonary fluid overload, formation/worsening of a pulmonary edema (defined as bilateral infiltrations with a PaO2/FIO2 < 300 mmHg and/or positive fluid balance > 10% of admission weight)

or

relative criteria: critical ill patient with acute kidney injury KDIGO 2 or 3 and fullfillment of all three of the following:
1. septic shock
2. age 18-90 years
3. full critical care support planned for at least 3 days

Exclusion Criteria

- Not meeting inclusion criteria
- Patient refusal
- Technically imposssible to conduct renal replacement therapy
- Preexisting congestive heart failure, defined as New York Heart Association Klassifikation = II and/or a preexisting left ventricular ejection fraction of < 40%
- Heparin allergy or contraindications against heparin use
- Suspicion of or confirmed heparin induced thrombocytopenia
- Pregnancy
- Inclusion in another interventional study
- Iatrogenic immunsuppression

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to resolution of septic shock, defined as a catecholamine dose of norepinephrine <0.2 ug / kg / min