Trial to Define a Standard and Evaluate the Incidence of Capillary Leak Syndrome in Adult Critical Care Medicine
- Conditions
- Capillary Leak CLS
- Registration Number
- DRKS00012713
- Lead Sponsor
- Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
1. Age = 18 years
2. Arm2 + Arm3: Estimated length of ICU stay = 48 hours
3. Consent of the patient, of next-of-kin or legal guardian
Exclusion Criteria
1. Refusal to participate of the patient, of next-of-kin or legal guardian
2. Idiopathic Capillary Leak Syndrome (ICLS, Clarkson's Disease)
3. HIV infection
4. Viral hepatitis
5. Hereditary C1-esterase deficiency
6. Recurrent Angioedema
7. Pre-existing chronic kidney failure on requiring dialysis
8. Pre-existing hepatic impairment with MELD score = 20
9. Participation in other clinical trials, especially pharmacological studies
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o a priori definition of a primary endpoint is possible in the described study: Goal of this study is to define criteria of CLS, thus characteristic parameters of CLS are to be identified in a first step of data analysis. Following data acquisition, independent variables will be calculated for patients who developed CLS. For this purpose, three cohorts were defined, comparing usual routine and study parameters: 1) Healthy volunteers, 2) critically ill patients on the intensive care unit, who do not show CLS according to clinical judgement, and 3) critically ill patients on the intensive care unit, who express CLS according to clinical judgement.
- Secondary Outcome Measures
Name Time Method