Clinical trial · Interventional
Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness
Evaluation of Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness in Septic Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
43 patients between 18-60 years presenting with criteria of sepsis (life-threatening organ dysfunction caused by a dysregulated host response to infection, suspected or documented infection and an acute increase ≥2 SOFA \[Sequential Organ Failure Assessment\] points) will be enrolled in our study. Approval of the ethical committee and informed written consent from first degree relatives will be issued. They will be given a full and detailed explanation of the intended study protocol and will be informed about the potential benefits of the development of a successful technique as well as the potential side-effects. To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tissue Perfusion | — | UNRESOLVED | — |
| Volume Overload | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fujifilm Sonosite M-Turbo C Ultrasound system | Device | — | UNRESOLVED |
| OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Non-invasive cardiometry
- description
- OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 A technique for the non-invasive determination of SV, CO, cardiac index, stroke index and HR along with other hemodynamic parameters such as preload (Thoracic Fluid Index), afterload and others. The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other above-mentioned parameters.
- interventionNames
- Device: OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3
- Device: Fujifilm Sonosite M-Turbo C Ultrasound system
Primary outcomes (1)
- measure
- Inferior vena cava collapsibility index
- timeFrame
- 6 hours
- description
- The ultrasound guided IVC collapsibility index will be correlated with to the cardiac index determined by the non-invasive cardiometry to determine which is more effective.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * ASA class I and II * 18yrs ≥ Age ≤ 60yrs * Fulfilling criteria of sepsis, as per The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) Exclusion Criteria: * Lack of consent * Active bleeding * Age \< 18yrs or \> 60yrs * Anticipated surgery or dialysis in the next 8hrs * Aortic regurge * Arrythmias * Cardiac tamponade * Chest wall oedema * Child B and Child C hepatic patients * Congestive heart failure * End-stage kidney disease (ESKD) patients with a creatinine clearance (CrCl) \<50ml/min * Massive bilateral pleural effusion * Mechanical ventilation * More than 4hrs after meeting criteria of septic shock * New York Heart Association (NYHA) III and IV cardiac patients * Severe ARDS (acute respiratory distress syndrome) * Tense ascites * Vasopressor infusion (before or after inclusion in the study)
References
Publications (0)
Data not yet available