Role of inflammatory markers and response to energy and protein delivery in critically ill patients, a pilot, proof-of-concept, prospective observational study

Role of inflammatory markers and response to energy and protein delivery in critically ill patients, a pilot, proof-of-concept, prospective observational study - REFINE-ICU

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040109

Enrollment

100

Registered

2026-04-29

Start date

2026-05-18

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Interaction between inflammatory markers and clinical nutrition in critically ill patients

Interventions

Group 1: Observation group: Patients over 18 years of age, on mechanical ventilation, and with an expected ICU stay of at least 4 days at the time of study enrollment. Based on (point-of-care) cytokin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Mechanical ventilation Expected ICU stay of 4 or more days

Exclusion criteria

Exclusion criteria: Moribund condition or expected withdrawal of life-sustaining measures within the next 24 hours Expected lack of consent for study participation based on the known wishes of the patient, or refusal by the patient or legal representative

Design outcomes

Primary

Measure	Time frame
Mortality 90 days after study inclusion, assessed by interview.	—

Secondary

Measure	Time frame
ICU-free days, up to 90 days, assessed using data from the hospital information system Ventilator-free days, up to 90 days, assessed using data from the hospital information system Quality of life after 90 days, measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), assessed by interview Handgrip strength at discharge from the intensive care unit and from the hospital, measured using a JAMAR handgrip dynamometer Discharge destination, assessed using data from the hospital information system Organ dysfunction during the ICU stay, assessed using data from the hospital information system Cell biological analyses of the humoral and cellular immune response as well as the course of inflammation through blood sampling within 24 hours after ICU admission and on days 3, 7, 10, and up to a maximum of day 14.	—

Measure

Time frame

ICU-free days, up to 90 days, assessed using data from the hospital information system Ventilator-free days, up to 90 days, assessed using data from the hospital information system Quality of life after 90 days, measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), assessed by interview Handgrip strength at discharge from the intensive care unit and from the hospital, measured using a JAMAR handgrip dynamometer Discharge destination, assessed using data from the hospital information system Organ dysfunction during the ICU stay, assessed using data from the hospital information system Cell biological analyses of the humoral and cellular immune response as well as the course of inflammation through blood sampling within 24 hours after ICU admission and on days 3, 7, 10, and up to a maximum of day 14.

—

Countries

Germany

Contacts

Public ContactQuirin Notz

Universitätsklinikum Würzburg, Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie

notz_q@ukw.de+49 931 20130017

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026