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The PUSH-1 trial is a randomized, single-center pilot trial investigating whether dobutamine administration is feasible in patients having major abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dobutamine administration | Experimental | In patient assigned to dobutamine administration, dobutamine (concentration: 5 mg mL-1) will be administered with an infusion rate of 3 µg kg-1 min-1 (ideal body weight). Dobutamine administration will start with the beginning of surgery and will end after the end of surgery (incision-to-suture). The treating anesthesiologist may increase or stop dobutamine administration if clinically indicated. Whenever dobutamine-induced tachycardia (defined as a heart rate ≥120 beats per minute) or new-onset cardiac arrhythmia is noted, dobutamine administration will be stopped. Restarting dobutamine administration is at the discretion of the treating anesthesiologist. |
|
| Routine care | Active Comparator | In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dobutamine | Drug | In patient assigned to dobutamine administration, dobutamine (concentration: 5 mg mL-1) will be administered with an infusion rate of 3 µg kg-1 min-1 (ideal body weight). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of dobutamine administration | The primary outcome "feasibility of dobutamine administration" is defined as dobutamine administration during >70% of surgery duration in >80% of all patients. | During surgery (incision-to-suture) |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial hypotension | Time-weighted average mean arterial pressure below 65 mmHg [mmHg] | During surgery (incision-to-suture) |
| Stroke volume index | Median stroke volume index [mL m-2] |
| Measure | Description | Time Frame |
|---|---|---|
| Severe tachyarrhythmias | Incidence of severe tachyarrhythmias (severe tachycardia defined as a heart rate >120 beats per minute or new abnormal heart rhythms) | During surgery (incision-to-suture) |
| Blood loss |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alina Bergholz, MD | University Medical Centre Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D004280 | Dobutamine |
| ID | Term |
|---|---|
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
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| Routine care | Other | In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care. |
|
| During surgery (incision-to-suture) |
| Heart rate | Median heart rate [beats per minute] | During surgery (incision-to-suture) |
| Cardiac index | Median cardiac index during surgery [L min-1 m-2] | During surgery (incision-to-suture) |
| Norepinephrine amount | Total amount of administered norepinephrine divided by body weight and surgical duration [µg kg-1 min-1] | During surgery (incision-to-suture) |
Estimated blood loss [mL]
| During surgery (incision-to-suture) |
| Amount of fluids | Total amount of fluid administration divided by surgical duration [mL h-1] | During surgery (incision-to-suture) |
| Red blood cell transfusion | Red blood cell transfusion requirements [units] | During surgery (incision-to-suture) |
| Urine output | Total urine output divided by surgical duration [mL h-1] | During surgery (incision-to-suture) |
| Hospital length of stay | Hospital length of stay [days] | Assessed up to 3 months |
| Rehospitalization | Rehospitalization within 30 days after surgery (assessed based on electronic health records and/or telephone interviews) | Within 30 days after surgery |
| Postoperative complications | Incidence of postoperative complications (assessed based on electronic health records and/or telephone interviews): acute myocardial infarction, acute kidney injury, stroke, surgical site infection, sepsis, infection requiring antibiotic treatment, renal replacement therapy, non-fatal cardiac arrest, and death | Within 30 days after surgery |
| D005021 |
| Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |