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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029259
Enrollment
10
Registered
2022-06-08
Start date
2023-01-11
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Interventions

Group 1: Intervention: Lowering the core body temperature to 34°C Intervention period: 48h from reaching the target temperature

Sponsors

Charité Campus Virchow-Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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 6h) with optimal ventilation and VV ECMO therapy - Deep analgosedation (RASS -5)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Oxygen saturation and oxygen partial pressure (pO2) before, during and after intervention

Secondary

MeasureTime frame
Gas exchange: - 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) - Blood and gas flow at the VV-ECMO - Duration of ventilation - Duration of ECMO therapy Hemodynamics: - Heart rate - Documentation of any rhythm abnormalities - Blood pressure analysis (sys / dias / MAD) - Catecholamine supplies Laboratory findings: - Infection values - Liver, heart and kidney function - VEGF as a hypoxia marker - kidney values - Blood count - Coagulation - Electrolyte balance Other: - mortality (30 days or until discharge from the intensive care unit),

Countries

Germany

Contacts

Public ContactJulius Kunz

Klinik für Nephrologie und IntensivmedizinCampus Charité MitteCharité - Universitätsmedizin Berlin

Julius-Valentin.Kunz@charite.de030 450 614636

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026