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Comparison of personalized hemodynamic management with pulse-pressure-variation–guided fluid therapy and standard therapy in elective neurosurgical tumor resections

Comparison of personalized hemodynamic management with pulse-pressure-variation–guided fluid therapy and standard therapy in elective neurosurgical tumor resections

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040966
Enrollment
72
Registered
2026-07-15
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

intracranial tumors

Interventions

Group 1: Personalized hemodynamic management: Participants receive individualized hemodynamic management aimed at maintaining the cardiac index determined echocardiographically on the evening before s

Sponsors

Medizinische Fakultät der Universität Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Elective intracranial tumor resection. Written informed consent obtained prior to study participation.

Exclusion criteria

Exclusion criteria: - Chronic kidney disease (estimated glomerular filtration rate 40 mmHg) - Acute myocardial ischemia within 30 days prior to randomization - Peripheral arterial occlusive disease (Fontaine stage =IIb) - Respiratory system compliance <30 mL/cmH2O - Preoperative hemoglobin concentration <10 g/dL - Inability to obtain a reliable preoperative baseline cardiac index because of inadequate echocardiographic image quality (Ultrasound befor randomization)

Design outcomes

Primary

MeasureTime frame
Total time in which the continuously pulse contour analysis-derived cardiac index (CI) remains within the individually predefined preoperative target range (personalized CI = CI-actual = 1.2 × personalized CI). The outcome will be assessed over the entire intraoperative observation period, from induction of anesthesia until completion of surgery.

Secondary

MeasureTime frame
Hemodynamic outcomes: Systolic blood pressure Mean arterial pressure (MAP) Systemic vascular resistance index (SVRI) Catecholamine dose requirements Oxygen delivery (DO2) Central venous-to-arterial carbon dioxide partial pressure difference (CO2 gap) Total intraoperative fluid administration Regional cerebral oxygen saturation measured by near-infrared spectroscopy (NIRS) Metabolic outcomes: Serum sodium concentration Serum osmolality Osmolal gap Clinical outcomes: Postoperative nausea and vomiting (PONV) Composite postoperative complications according to the European Perioperative Clinical Outcome (EPCO) definitions Length of stay in the intensive care unit (ICU) Length of hospital stay Neurological outcome during hospitalization and at hospital discharge In-hospital mortality

Countries

Germany

Contacts

Public ContactFranz-Simon Centner

Medizinische Fakultät der Universität Heidelberg

Franz-Simon.Centner@umm.de+49 621 383 74614

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026