Intraoperative Myocardial DepressionPUSH-1NCT07000994
Dobutamine During Major Abdominal Surgery
A study testing Dobutamine and Routine care in people with Intraoperative Myocardial Depression, run by University of Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The PUSH-1 trial is a randomized, single-center pilot trial investigating whether dobutamine administration is feasible in patients having major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Myocardial Depression
- What is being tested?
- Dobutamine and Routine care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jun 2025to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: Dobutamine During Major Abdominal Surgery: A Randomized Pilot Trial (PUSH-1)
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
- Being tested
- Dobutamine, Routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
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 careOther
In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dobutamine |
| Routine care | Active comparator | In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery (incision-to-suture)
Secondary outcomes (5)
Arterial hypotension
Time-weighted average mean arterial pressure below 65 mmHg [mmHg]
Measured: During surgery (incision-to-suture)
Stroke volume index
Median stroke volume index [mL m-2]
Measured: During surgery (incision-to-suture)
Heart rate
Median heart rate [beats per minute]
Measured: During surgery (incision-to-suture)
Cardiac index
Median cardiac index during surgery [L min-1 m-2]
Measured: During surgery (incision-to-suture)
Norepinephrine amount
Total amount of administered norepinephrine divided by body weight and surgical duration [µg kg-1 min-1]
Measured: During surgery (incision-to-suture)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start16 Jun 2025
- Primary completion28 Jan 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Myocardial DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alina Bergholz, University of Hamburg-Eppendorf
- Investigators
- Alina Bergholz, MD, Principal investigator, University Medical Centre Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000994
- Sponsor's protocol ID
- 2022-100915-BO-ff
- Acronym
- PUSH-1
- Status last verified
- Apr 2026
- First submitted
- 14 May 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dobutamine During Major Abdominal Surgery: A Randomized Pilot Trial (PUSH-1)
- ClinicalTrials.gov ID
- NCT07000994
- Acronym / sponsor ID
- PUSH-1 / 2022-100915-BO-ff
- Conditions
- Intraoperative Myocardial Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Hamburg-EppendorfUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PUSH-1 trial is a randomized, single-center pilot trial investigating whether dobutamine administration is feasible in patients having major abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dobutamine administration | Experimental | Drug: DobutamineIn 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 | Other: Routine careIn patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Emergency surgery
- Liver or kidney transplantation surgery
- Status of post transplantation of kidney, liver, heart, or lung
- Pregnancy
- Heart rhythms other than sinus rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DobutamineIn 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). | Drug | Dobutamine administration |
| Routine careIn patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care. | Other | Routine care |
Primary outcome
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.
5 secondary outcomes
Arterial hypotension
Time frame: During surgery (incision-to-suture)
Stroke volume index
Time frame: During surgery (incision-to-suture)
Heart rate
Time frame: During surgery (incision-to-suture)
Cardiac index
Time frame: During surgery (incision-to-suture)
Norepinephrine amount
Time frame: During surgery (incision-to-suture)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Bergholz, MD principal investigator
University Medical Centre Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dobutamine and Routine care in people with Intraoperative Myocardial Depression, run by University of Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of dobutamine administration (time frame: During surgery (incision-to-suture)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.