Dobutamine During Major Abdominal Surgery

Not Applicable

Not yet recruiting

• Conditions: Intraoperative Myocardial Depression
• Interventions: Drug: Dobutamine; Other: Routine care

• Registration Number: NCT07000994
• Lead Sponsor: University of Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study Start: 2025-06
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dobutamine administration	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). 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	Routine care	In patients assigned to routine care, intraoperative hemodynamic management will be in accordance with routine care.

Primary Outcome Measures

Name	Time	Method
Feasibility of dobutamine administration	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 Outcome Measures

Name	Time	Method
Arterial hypotension	During surgery (incision-to-suture)	Time-weighted average mean arterial pressure below 65 mmHg \[mmHg\]
Stroke volume index	During surgery (incision-to-suture)	Median stroke volume index \[mL m-2\]
Heart rate	During surgery (incision-to-suture)	Median heart rate \[beats per minute\]
Cardiac index	During surgery (incision-to-suture)	Median cardiac index during surgery \[L min-1 m-2\]
Norepinephrine amount	During surgery (incision-to-suture)	Total amount of administered norepinephrine divided by body weight and surgical duration \[µg kg-1 min-1\]

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany