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| Name | Class |
|---|---|
| Northern State Medical University | OTHER |
| Szeged University | OTHER |
| University of Kiel | OTHER |
| University of Witten/Herdecke |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | 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 |
|
| Control group | No Intervention | hemodynamic management according to institutional clinical standards |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| measurement of cardiac output and pulse pressure variation | Device | hemodynamic optimization according to cardiac index and pulse pressure variation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Stay | length of stay in the postoperative care unit, length of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Reuter, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20251 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24010849 | Derived | Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control Group | hemodynamic management according to institutional clinical standards |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | numbers of 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel A. Reuter, MD | Hamburg Eppendorf University Hospital | +49-40-7410-0 | dreuter@uke.de |
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| OTHER |
| University of Valencia | OTHER |
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| no central venous access |
|
| suspicion of malignant hyperthermia |
|
hemodynamic management according to institutional clinical standards |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
hemodynamic management according to institutional clinical standards |
|
|
| Secondary | Hospital Stay | length of stay in the postoperative care unit, length of hospital stay | Posted | Median | Inter-Quartile Range | days | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Control Group | hemodynamic management according to institutional clinical standards | 0 | 81 | 0 | 81 |
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