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Dobutamine for Tissue Oxygenation

Phase 1 & 2
Recruiting
Led By Glenio B. Mizubuti, MD, MSc, FRCPC
Research Sponsored by Dr. Glenio Mizubuti (MD, MSc)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately preoperatively until up to 48 hours postoperatively
Awards & highlights

Study Summary

This trial will test whether a combination of optimal fluid therapy and dobutamine improves flap oxygenation in DIEP flap patients.

Who is the study for?
This trial is for individuals competent to consent, undergoing elective DIEP flap breast reconstruction surgery with a physical health status classified as I-III. It excludes those with additional surgeries planned, severe heart or kidney issues, liver insufficiency, extreme body weights, cognitive impairments, dobutamine contraindications, and pregnant or lactating women.Check my eligibility
What is being tested?
The study tests if combining optimal fluid therapy guided by cardiac output with dobutamine improves tissue oxygenation in patients having DIEP flap surgery for breast reconstruction. Patients are randomly assigned to this new approach or the standard care and monitored using near-infrared spectroscopy post-surgery.See study design
What are the potential side effects?
Dobutamine may cause side effects such as increased heart rate, irregular heartbeat, blood pressure changes and possible reactions at the injection site. The severity of these side effects can vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately preoperatively until up to 48 hours postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately preoperatively until up to 48 hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Complications Associated with Flap Mal-Perfusion
DAOH
Hospital Length of Stay
+4 more

Side effects data

From 2011 Phase 2 trial • 33 Patients • NCT00624650
12%
Death
6%
Hypernatremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FACTT (Control)
EVLW

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dobutamine + Goal-Directed Fluid TherapyExperimental Treatment1 Intervention
All patients will receive a baseline infusion of Ringer's lactate at 2 ml/kg/h to satisfy maintenance fluid requirements. The intervention will commence at anesthesia induction and continue for up to 4 hours postoperatively. In addition to maintenance fluids, patients will receive 250 ml fluid challenges with crystalloid as required until they are no longer fluid responsive. The absence of fluid responsiveness will be defined as the absence of a sustained rise in stroke volume index of at least 10% for 20 minutes or more, at which point, the patient will be considered fluid optimized. At this point, a low-dose dobutamine infusion at a fixed rate (2.5 μg/kg/min) will be commenced and maintained until 4 hours postoperatively. The infusion rate will be halved and/or discontinued if the patient develops tachycardia (heart rate ≥ 100 bpm) for more than 30 minutes despite adequate anesthesia/analgesia and fluid status.
Group II: Standard of careActive Control1 Intervention
Patients in the control group will also receive a baseline infusion of Ringer's lactate at 2 ml/kg/h to satisfy maintenance fluid requirements, which will be commenced upon admission to the operating room. The anesthetic management will otherwise be according to standard practice. No specific cardiac output monitoring device will be used to guide fluid therapy. Likewise, perioperative dobutamine will not be used unless clinically indicated to improve cardiac function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dobutamine
2011
Completed Phase 4
~23230

Find a Location

Who is running the clinical trial?

Dr. Glenio Mizubuti (MD, MSc)Lead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Queen's UniversityLead Sponsor
369 Previous Clinical Trials
121,525 Total Patients Enrolled
Glenio B. Mizubuti, MD, MSc, FRCPCPrincipal InvestigatorQueen's University - Anesthesiology
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Dobutamine + Goal-Directed Fluid Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04020172 — Phase 1 & 2
Perioperative Tissue Oxygenation Research Study Groups: Dobutamine + Goal-Directed Fluid Therapy, Standard of care
Perioperative Tissue Oxygenation Clinical Trial 2023: Dobutamine + Goal-Directed Fluid Therapy Highlights & Side Effects. Trial Name: NCT04020172 — Phase 1 & 2
Dobutamine + Goal-Directed Fluid Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04020172 — Phase 1 & 2
~7 spots leftby Jun 2025
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