Multi-center, Prospective, Randomized Outcome Study Comparing Continuous Cardiac Index Trending Via a Radial Arterial Line Versus Standard Care in General Surgical Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Postoperative Complications
Study Overview
Brief Summary
This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients
Detailed Description
This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •major abdominal surgery
- •duration of surgery > 2 hours
Exclusion Criteria
- •age < 18 years
- •scheduled postoperative icu treatment
Outcomes
Primary Outcomes
Postoperative Complications
Time Frame: Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days
Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output \<500ml/d, ARF)
Secondary Outcomes
- Hospital Stay(Participants will be followed for the duration of hospital stay, an expected average of 10 days)