Skip to main content
OpenTrials
Completed

NCT Number: NCT07000994

Dobutamine During Major Abdominal Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intraoperative Myocardial Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Routine care

Other

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

Primary outcomes

  1. Feasibility of dobutamine administration

    Time frame: 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 outcomes

  1. Arterial hypotension

    Time frame: During surgery (incision-to-suture)

    Time-weighted average mean arterial pressure below 65 mmHg [mmHg]

  2. Stroke volume index

    Time frame: During surgery (incision-to-suture)

    Median stroke volume index [mL m-2]

  3. Heart rate

    Time frame: During surgery (incision-to-suture)

    Median heart rate [beats per minute]

  4. Cardiac index

    Time frame: During surgery (incision-to-suture)

    Median cardiac index during surgery [L min-1 m-2]

  5. Norepinephrine amount

    Time frame: During surgery (incision-to-suture)

    Total amount of administered norepinephrine divided by body weight and surgical duration [µg kg-1 min-1]

Other outcomes

  1. Severe tachyarrhythmias

    Time frame: During surgery (incision-to-suture)

    Incidence of severe tachyarrhythmias (severe tachycardia defined as a heart rate >120 beats per minute or new abnormal heart rhythms)

  2. Blood loss

    Time frame: During surgery (incision-to-suture)

    Estimated blood loss [mL]

  3. Amount of fluids

    Time frame: During surgery (incision-to-suture)

    Total amount of fluid administration divided by surgical duration [mL h-1]

  4. Red blood cell transfusion

    Time frame: During surgery (incision-to-suture)

    Red blood cell transfusion requirements [units]

  5. Urine output

    Time frame: During surgery (incision-to-suture)

    Total urine output divided by surgical duration [mL h-1]

  6. Hospital length of stay

    Time frame: Assessed up to 3 months

    Hospital length of stay [days]

  7. Rehospitalization

    Time frame: Within 30 days after surgery

    Rehospitalization within 30 days after surgery (assessed based on electronic health records and/or telephone interviews)

  8. Postoperative complications

    Time frame: Within 30 days after surgery

    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

Sponsors and collaborators

Lead sponsor

University of Hamburg-Eppendorf

Other

Registry information

Official study title

Dobutamine During Major Abdominal Surgery: A Randomized Pilot Trial (PUSH-1)

Acronym: PUSH-1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.