Dobutamine During Major Abdominal Surgery

NCT07000994 | Completed

• 1 other identifier: 2022-100915-BO-ff
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Myocardial Depression

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Arterial hypotension

  During surgery (incision-to-suture)

• Stroke volume index

  During surgery (incision-to-suture)

• Heart rate

  During surgery (incision-to-suture)

• Cardiac index

  During surgery (incision-to-suture)

• Norepinephrine amount

  During surgery (incision-to-suture)

Other Outcomes (8)

• Severe tachyarrhythmias

  During surgery (incision-to-suture)

• Blood loss

  During surgery (incision-to-suture)

• Amount of fluids

  During surgery (incision-to-suture)

Study Arms (2)

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.

Drug: Dobutamine

Routine care

ACTIVE COMPARATOR

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

Other: Routine care

Interventions

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).

Dobutamine administration

Routine care OTHER

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

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Emergency surgery
• Liver or kidney transplantation surgery
• Status of post transplantation of kidney, liver, heart, or lung
• Pregnancy
• Heart rhythms other than sinus rhythm

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Location

MeSH Terms

Interventions

Dobutamine

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Alina Bergholz, MD

  University Medical Centre Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 3, 2025
• Study Start: June 16, 2025
• Primary Completion: January 28, 2026
• Study Completion: February 27, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)