Skip to content

Intraoperative Evaluation of Circulation, Metabolism and Body Composition (INTRICATE Study)

Intraoperative Evaluation of Circulation, Metabolism and Body Composition (INTRICATE Study) - INTRICATE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034993
Enrollment
100
Registered
2024-11-06
Start date
2024-10-22
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Patients undergoing elective surgery with an anticipated duration of at least 180 minutes

Interventions

Group 1: Adult Patients undergoing elective surgery with an estimated duration of at least 180 minutes. At predefined measuring timepoints (study inclusion, before surgery after hospital admission, ho

Sponsors

Uniklinik RWTH Achen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Given informed consent 2. Adult patients (= 18 years) 3. Elective major surgery with anticipated duration of > 180 minutes 4. Patients receiving central venous and arterial access as per clinical routine

Exclusion criteria

Exclusion criteria: • Patients < 18 years, pregnant or lactating patients • Patients unable to consent or follow instructions from medical team (cognitive, psychiatric, or severe language barriers) • Medical conditions, surgical and anesthesia-related procedures preventing the intraoperative use of the planned medical devices • Propofol allergy as contraindication for total intravenous anesthesia (TIVA) • Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case-by-case basis)

Design outcomes

Primary

MeasureTime frame
1)Correlation of intraoperative mean arterial pressure (MAP) and resting energy expenditure (REE) 2)Correlation of muscle mass and anesthesia related outcomes

Secondary

MeasureTime frame
1) Laboratory outcomes: Blood gas analyses (longitudinal assessment) Lactate Arteriovenous difference in partial pressures Central venous oxygen saturation 2) Metabolic outcomes (longitudinal assessment): Indirect calorimetry Body composition Perioperative blood glucose and insulin Quadriceps mass and elastography 3) Clinical outcomes Hemodynamics Vasopressor treatment Fluid balance on the day of surgery Perioperative transfusions Mechanical ventilation Complications after surgery until hospital discharge or until 7 days after surgery Hospital-mortality Length of stay 4) Anesthesia related outcomes Duration of mechanical ventilation Dosage of opioids, hypnotics and muscle relaxants Use of antidots for opioids, benzodiazepines and muscle relaxants Intraoperative depth of anesthesia Intraoperative microcirculation Anesthesia related adverse events

Countries

Germany

Contacts

Public ContactAileen Hill

Uniklinik RWTH Aachen

ahill@ukaachen.de+492418038166

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026