N/A
Completed N=68
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
Source: ClinicalTrials.gov NCT02701582 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Number of ICU Stays Greater Than 1.5 Days — 13; 20 Number of ICU Stays greater that 1.5 Day
Summary
This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection complicated by cerebral edema, or complex spinal surgery including multi-level scoliosis correction, is a more effective way of monitoring fluid.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of ICU Stays Greater Than 1.5 Days |
13; 20 | — |
| SECONDARY Creatinine Change |
-0.04; -0.13 | — |
Eligibility Criteria
Inclusion Criteria
- Neurosurgical patients with concerns for decreased intracranial compliance;
- Orthopedic spine patients;
- Patients scheduled to undergo neurosurgical interventions that include any of the following will be eligible: intracranial aneurysm repair; or, major spine surgery.
Exclusion Criteria
- Patients with permanent cardiac arrhythmias;
- Patients with severe aortic regurgitation;
- Patients with intra-aortic balloon pump (IABP);
- Patients undergoing emergency surgery; and,
- Women who are pregnant and/or nursing will be excluded.
Data sourced from ClinicalTrials.gov (NCT02701582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.