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Effects of Induced Hypothermia on Respiratory parameters and Immunological function

Effects of Induced Hypothermia on Respiratory parameters and Immunological function - REIM study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34602
Enrollment
60
Registered
2010-09-20
Start date
2011-03-07
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Hypothermia

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For the observational part of the study: - Admission to the ICU after cardio pulmonary resuscitation - Treatment with induced mild hypothermia according to protocol, as part of standard patient care For the case-control part of the study, 2 additional groups will be included: - Mechanically ventilated normothermic, non-infectious patients - Healthy volunteers

Exclusion criteria

Exclusion criteria: Exclusion cirteria are: - No informed consent - Inability to complete 24 hours of hypothermia - Presence of pulmonary fibrosis

Design outcomes

Primary

MeasureTime frame
The main endpoint of this study is P/F ratio as a measure of oxygenation and end tidal CO2 as a measure of ventilation.

Secondary

MeasureTime frame
Respiratory: oxygenation index, lung injury score, static compliance, dead space ventilation, oxygen consumption. Immunological: levels of pro-inflammatory chemokines and cytokines (TNF-alpha, Il-1beta, and IL-6, IL-2, IFN-g, IL-8), whole blood stimulation, HLA-DR expression.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)