Trial to Define a Standard and Evaluate the Incidence of Capillary Leak Syndrome in Adult Critical Care Medicine

Trial to Define a Standard and Evaluate the Incidence of Capillary Leak Syndrome in Adult Critical Care Medicine - SIC-CAP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012713

Enrollment

250

Registered

2017-10-05

Start date

2018-02-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Capillary Leak CLS

Interventions

Group 1: Healthy volunteers: Anonymous and one-time data gathering of biographic and constitutional data as well as measuring of blood parameters and performance of routine- and study-related exams, s

Daily data gathering as well as follow-up: Requisition of data for patient course, weight, fluids, medication, scores etc. as well as routine blood parameters (clinical chemistry, coagulation, blood c

Data gathering identical to arm2

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
No 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.	—

Measure

Time frame

No 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.

—

Countries

Germany

Contacts

Public ContactJakob Wollborn

Klinik für Anästhesiologie und Intensivmedizin, Uniklinik Freiburg

jakob.wollborn@uniklinik-freiburg.de+49-761-270-23060

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026