Haemodynamic monitoring to optimize intraoperative perfusion during free flap surgery and detection of systemic inflammatory response

Haemodynamic monitoring to optimize intraoperative perfusion during free flap surgery and detection of systemic inflammatory response - HAEMOptis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037494

Enrollment

100

Registered

2025-10-13

Start date

2025-10-15

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

The extent of inflammation and endothelial damage on the volume/catecholamine requirements during free flap surgery is being investigated

Interventions

Group 1: The observational cohort includes all patients undergoing free flap surgery who meet the inclusion criteria, no interventional cohort. As part of this study, blood parameters will be assesse

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age > 18 years - Free flap reconstruction from the following specialties: oral and maxillofacial surgery, hand surgery, plastic surgery (the soft tissue defect may be pre-existing or planned as part of a procedure, e.g., tumor resection) - informed consent given by patients

Exclusion criteria

Exclusion criteria: - Pregnancy - Age < 18 years - Refusal to participate in the study by patients capable of giving informed consent - previous free flap transfer (FLT) performed at the same anatomical site - coagulation disorders / ongoing anticoagulant medication - current immunosuppressive therapy - atrial fibrillation - chronic inflammatory diseases (COPD, chronic inflammatory bowel diseases, rheumatoid disease spectrum)

Design outcomes

Primary

Measure	Time frame
The volume requirement to maintain normovolemia during free flap transfer correlates with intraoperative interleukin-6 levels. The aim of this study is to investigate the correlation between interleukin-6 levels and the fluid/volume requirements necessary to maintain intraoperative normovolemia, as assessed by hemodynamic monitoring.	—

Secondary

Measure	Time frame
The volume requirement to maintain normovolemia during free flap transfer increases with the extent of D-dimer and fibrinogen levels The occurrence of postoperative complications (defined as any adverse event requiring medical intervention or impacting the length of hospital stay) correlates with IL-6 levels and D-dimer concentrations	—

Countries

Germany

Contacts

Public ContactAdina Bathel

Unfallkrankenhaus Berlin

adina.bathel@ukb.de+49 30 5681 5148

Outcome results

None listed

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