Clinical trial · Interventional
Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
NCT00526331CI-TRIAL-00006062completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether the early identification and more precise intervention of operating room (OR) patient fluid administration optimization using arterial pressure-based cardiac output (APCO) yields comparable patient outcome as fluid administration optimization using a global standard care method.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disorder of the Genitourinary System | — | UNRESOLVED | — |
| Esophageal Diseases | — | UNRESOLVED | — |
| Gastrointestinal Diseases | — | UNRESOLVED | — |
| Gynecologic Diseases | — | UNRESOLVED | — |
| Kidney Diseases | — | UNRESOLVED | — |
| Liver Diseases | — | UNRESOLVED | — |
| Pancreatic Diseases | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Spinal Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FloTrac Sensor | Device | — | UNRESOLVED |
| Vigileo Monitor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Group
- description
- FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery.
- interventionNames
- Device: Vigileo Monitor
- Device: FloTrac Sensor
- type
- EXPERIMENTAL
- label
- Control Group
- description
- FloTrac Sensor + Vigileo Monitor only used for data collection during surgery; Standard of Care to decide fluid amount.
- interventionNames
- Device: Vigileo Monitor
- Device: FloTrac Sensor
Primary outcomes (1)
- measure
- Length of Hospital Stay (LOS) by Participant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is in hospital for study indicated treatment. 2. Patient is able to comply with the study procedure. 3. Patient must require an indwelling radial or a femoral artery catheter. 4. Patients with an American Society of Anesthesiologists Risk Score \>= 3. 5. Lee Risk Index \>/= 2 (Hypertension and Pre-diabetic metabolic state). 6. Patient must be 40 kg or heavier. 7. Patient has consented to be in the trial. 8. Patient's height and weight can be accurately obtained prior to study start. 9. Patient's ability to undergo major surgery with an anticipated blood loss \> 500 ml. Exclusion Criteria: 1. Patients with contraindications for the placement of radial, femoral, or other arterial cannula. 2. Patients with contraindications for the placement of central venous cannula. 3. Patients being treated with an intra-aortic balloon pump. 4. Patients with aortic valve regurgitation. 5. Patients with atrial fibrillation. 6. Female patients with a known pregnancy confirmed by urine pregnancy test. 7. Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
References
Publications (0)
Data not yet available
No reference posted for this study.