Dobutamine During Major Abdominal Surgery (PUSH-1)

University of Hamburg-Eppendorf

Status: Enrolling

Conditions: Intraoperative Myocardial Depression

Treatments: Other: Routine care; Drug: Dobutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT07000994

2022-100915-BO-ff

Details and patient eligibility

About

The PUSH-1 trial is a randomized, single-center pilot trial investigating whether dobutamine administration is feasible in patients having major abdominal surgery.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Dobutamine administration

Experimental group

Description:

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.

Treatment:

Drug: Dobutamine

Routine care

Active Comparator group

Description:

In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care.

Treatment:

Other: Routine care