Dobutamine During Major Abdominal Surgery

NCT ID: NCT07000994

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2026-04-30

Brief Summary

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

Detailed Description

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Conditions

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Intraoperative Myocardial Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Dobutamine administration

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.

Group Type EXPERIMENTAL

Dobutamine

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type OTHER

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

Interventions

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Dobutamine

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).

Intervention Type DRUG

Routine care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Dr. Alina Bergholz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alina Bergholz, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Hamburg-Eppendorf

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alina Bergholz, MD

Role: CONTACT

+49 40 7410 0

Bernd Saugel, MD

Role: CONTACT

Facility Contacts

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Alina Bergholz, MD

Role: primary

+4940 7410 0

Karim Kouz, MD

Role: backup

Other Identifiers

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2022-100915-BO-ff

Identifier Type: -

Identifier Source: org_study_id

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