Prospective, single-center, open clinical trial to compare two non-calibrated systems for the continuous measurement of cardiac output and stroke volume variation (LiDCO rapid®, ICON®) with a calibrated system using Thermodilutionin (PiCCO®) in adult cardiac surgical patients.

Prospective, single-center, open clinical trial to compare two non-calibrated systems for the continuous measurement of cardiac output and stroke volume variation (LiDCO rapid®, ICON®) with a calibrated system using Thermodilutionin (PiCCO®) in adult cardiac surgical patients. - Hemodynamic Study 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005582

Enrollment

Registered

2014-01-14

Start date

2014-06-15

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

Diseases that make a determination of cardiac output and stroke volume variation necessary I97

Interventions

Group 1: Parallel testing LiDCO rapid® vs. ICON® vs. PiCCO®

Eligibility

Sex/Gender

All

Age

18 Years to 88 Years

Inclusion criteria

Inclusion criteria: • Planned determination of cardiac output (CO) and stroke volume variation (SVV) by a monitoring procedure in adult cardiac surgical patients. • Written consent of the patient.

Exclusion criteria

Exclusion criteria: • Absolute arrhythmia. • Spontaneous breathing. • ASA> 4 • infections or skin diseases in the area of possible puncture sites. • Participation in another interventional clinical trials. • diseases or disorders that makes the participation in this clinical trial not possible in the opinion of the investigator (support systems in operation (IABP, MECC), hemodynamic instability, catecholamine therapy).

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity obtained with the LiDCO rapid®, the PiCCO® and the ICON® apparatus parameters stroke volume variation (SVV) and pulse pressure variation (PPV) (excluding LiDCO rapid®) for the prediction of fluid responsiveness (change in cardiac output by = 10% by volume rendering) at different tidal volume (validation SVV, PPV)	—

Secondary

Measure	Time frame
• Sensitivity and specificity of the clinical "Passive Leg Raising test" to predict fluid responsiveness (same direction changes of cardiac output by = 10% after PLRT and volume administration) at different tidal volume (validation PLRT). • difference between the LiDCO rapid® and the ICON® determined hemodynamic parameters cardiac output (CO), stroke volume variation (SVV) and pulse pressure variation (PPV) (excluding LiDCO rapid®) and measured by PiCCO® values ??(validation LiDCO rapid® and ICON® vs. PiCCO®) calibrated taking into account the repetition accuracy of PiCCO® measurement method (PiCCO® vs. PiCCO® not calibrated) at different tidal volumes. • extent and direction of changes in the cardiac output associated with the highest sensitivity and specificity to changes in the parameters of fluid responsiveness (SVV, PPV).	—

Measure

Time frame

• Sensitivity and specificity of the clinical "Passive Leg Raising test" to predict fluid responsiveness (same direction changes of cardiac output by = 10% after PLRT and volume administration) at different tidal volume (validation PLRT). • difference between the LiDCO rapid® and the ICON® determined hemodynamic parameters cardiac output (CO), stroke volume variation (SVV) and pulse pressure variation (PPV) (excluding LiDCO rapid®) and measured by PiCCO® values ??(validation LiDCO rapid® and ICON® vs. PiCCO®) calibrated taking into account the repetition accuracy of PiCCO® measurement method (PiCCO® vs. PiCCO® not calibrated) at different tidal volumes. • extent and direction of changes in the cardiac output associated with the highest sensitivity and specificity to changes in the parameters of fluid responsiveness (SVV, PPV).

—

Countries

Germany

Contacts

Public ContactPatrick Braß

Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieHelios Klinikum Krefeld

patrick.brass@helios-kliniken.de+49 2151 32 45044

Outcome results

None listed

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