Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications
Conditions
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.
Interventions
DEVICEmeasurement of cardiac output and pulse pressure variation
hemodynamic optimization according to cardiac index and pulse pressure variation
Sponsors
Northern State Medical University
Szeged University
University of Kiel
University of Witten/Herdecke
University of Valencia
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* major abdominal surgery * duration of surgery \> 2 hours
Exclusion criteria
* age \< 18 years * scheduled postoperative icu treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 10 days | length of stay in the postoperative care unit, length of hospital stay |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation
measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation | 89 |
| Control Group hemodynamic management according to institutional clinical standards | 91 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | no central venous access | 0 | 1 |
| Overall Study | preoperative arrhythmia | 5 | 0 |
| Overall Study | surgery cancelled | 5 | 8 |
| Overall Study | suspicion of malignant hyperthermia | 0 | 1 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 36 Participants | 61 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 55 Participants | 119 Participants |
| Region of Enrollment Germany | 89 participants | 91 participants | 180 participants |
| Sex: Female, Male Female | 37 Participants | 36 Participants | 73 Participants |
| Sex: Female, Male Male | 52 Participants | 55 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 79 | 0 / 81 |
| serious Total, serious adverse events | 0 / 79 | 0 / 81 |
Outcome results
Primary
Postoperative Complications
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)
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | Postoperative Complications | 52 numbers of complications |
| Control Group | Postoperative Complications | 72 numbers of complications |
Secondary
Hospital Stay
length of stay in the postoperative care unit, length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Group | Hospital Stay | 11 days |
| Control Group | Hospital Stay | 10 days |