Intraoperative Myocardial Depression
Conditions
Brief summary
The PUSH-1 trial is a randomized, single-center pilot trial investigating whether dobutamine administration is feasible in patients having major abdominal surgery.
Interventions
DRUGDobutamine
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).
OTHERRoutine care
In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care.
Sponsors
University of 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
* Consenting patients ≥18 years scheduled for elective major abdominal surgery under general anesthesia (expected surgery duration ≥ 120 minutes) * Planned continuous intraarterial blood pressure monitoring using an arterial catheter for clinical indications not related to the trial
Exclusion criteria
* Emergency surgery * Liver or kidney transplantation surgery * Status of post transplantation of kidney, liver, heart, or lung * Pregnancy * Heart rhythms other than sinus rhythm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of dobutamine administration | During surgery (incision-to-suture) | The primary outcome "feasibility of dobutamine administration" is defined as dobutamine administration during \>70% of surgery duration in \>80% of all patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial hypotension | During surgery (incision-to-suture) | Time-weighted average mean arterial pressure below 65 mmHg \[mmHg\] |
| Stroke volume index | During surgery (incision-to-suture) | Median stroke volume index \[mL m-2\] |
| Heart rate | During surgery (incision-to-suture) | Median heart rate \[beats per minute\] |
| Cardiac index | During surgery (incision-to-suture) | Median cardiac index during surgery \[L min-1 m-2\] |
| Norepinephrine amount | During surgery (incision-to-suture) | Total amount of administered norepinephrine divided by body weight and surgical duration \[µg kg-1 min-1\] |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORAlina Bergholz, MD
University Medical Centre Hamburg-Eppendorf
Outcome results
None listed