The Theramax study – mild therapeutic hypothermia in hypoxic patients despite maximum VV-ECMO blood flow

Not Applicable

Recruiting

Conditions: ARDS

Registration Number: DRKS00029259

Lead Sponsor: Charité Campus Virchow-Klinikum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Age >18 years
- Intensive medical therapy with invasive mechanical ventilation of any indication
- VV-ECMO with blood flow > 5l/min
- Persistent hypoxia (pO² < 60mmHg; >6h) with optimal ventilation and VV ECMO therapy
- Deep analgosedation (RASS -5)

Exclusion Criteria

- Severe intra-abdominal, thoracic, gastrointestinal and/or intracerebral bleeding
- Hemophilia/severe thrombocytopenia (<20)
- Coagulation failure (Quick < 50)
- septic/cardiogenic shock
- Severe circulatory instability
- Pregnancy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxygen saturation and oxygen partial pressure (pO2) before, during and after intervention <br><br>

Secondary Outcome Measures

Name	Time	Method
Gas exchange:<br>- Blood gas analyses (BGA) (no additional samples are planned as part of the study, as BGAS is routinely performed every 2-4 hours in VV-ECMO patients)<br>- Blood and gas flow at the VV-ECMO<br>- Duration of ventilation <br>- Duration of ECMO therapy<br><br>Hemodynamics:<br>- Heart rate <br>- Documentation of any rhythm abnormalities<br>- Blood pressure analysis (sys / dias / MAD) <br>- Catecholamine supplies<br><br>Laboratory findings:<br>- Infection values<br>- Liver, heart and kidney function<br>- VEGF as a hypoxia marker<br>- kidney values<br>- Blood count<br>- Coagulation<br>- Electrolyte balance<br><br>Other:<br>- mortality (30 days or until discharge from the intensive care unit),