Dobutamine for Perioperative Tissue Oxygenation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kingston General Hospital, Kingston, Canada
Perioperative Tissue Oxygenation
Dobutamine - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether optimal fluid therapy in combination with dobutamine might improve flap oxygenation and thereby, reduce complications.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Dobutamine will improve 6 secondary outcomes in patients with Perioperative Tissue Oxygenation. Measurement will happen over the course of from date and time of end of surgery until the date and time of discharge from hospital or up to 30 days postoperatively (whichever comes first)..

Day 30
Patient satisfaction
complications associated with flap malperfusion
Day 30
Other complications
Hour 48
Intravenous fluids
tissue flap oxygenation
Day 30
length of stay

Trial Safety

Side Effects for

Modified FACTT (Control)
Death
12%
Hypernatremia
6%
This histogram enumerates side effects from a completed 2011 Phase 2 trial (NCT00624650) in the Modified FACTT (Control) ARM group. Side effects include: Death with 12%, Hypernatremia with 6%.

Trial Design

2 Treatment Groups

Standard of care
1 of 2
Dobutamine+fluid therapy
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dobutamine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Dobutamine+fluid therapy
Drug
All patients will receive a baseline infusion of Ringer's lactate at 3ml/kg/hr 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 250ml 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 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 4h postoperatively. The infusion rate will be halved and/or discontinued if the patient develops a tachycardia (heart rate ≥ 100bpm) for more than 30 minutes despite adequate anesthesia/analgesia and fluid status.
Standard of carePatients in the control group will also receive a baseline infusion of Ringer's lactate at 3ml/kg/hr 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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately preoperatively until up to 48 hours postoperatively
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly immediately preoperatively until up to 48 hours postoperatively for reporting.

Who is running the study

Principal Investigator
D. G. M. (.
Dr. Glenio Mizubuti (MDc), MD
Queen's University

Closest Location

Kingston General Hospital - Kingston, Canada

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
ASA I-III
Undergoing elective DIEP flap surgery
Competent to provide informed consent

Patient Q&A Section

Can perioperative tissue oxygenation be cured?

"These observations suggest that the current state of knowledge is insufficient to justify an attempt at restoring normoxic tissue oxygenation in the presence of clinically-relevant ischemia." - Anonymous Online Contributor

Unverified Answer

How many people get perioperative tissue oxygenation a year in the United States?

"Although perioperative tissue oxygenation is an important clinical measurement, perioperative tissue oxygenation has been largely neglected within the literature and is seldom reported in surgical literature. This needs to change." - Anonymous Online Contributor

Unverified Answer

What are common treatments for perioperative tissue oxygenation?

"Both the goal and the patient's willingness to take the therapies were predictive of achieving an adequate (measured) PO2. Use of a pulse oximeter in conjunction with vasopressors, diuretics, and/or oxygen supports improved perioperative O2 homeostasis through both increased blood flow and decreased tissue oxygenation." - Anonymous Online Contributor

Unverified Answer

What is perioperative tissue oxygenation?

"In a recent study, findings shows a wide range of perioperative levels of tissue oxygenation. There was no significant correlation between the level of tissue oxygenation during deep regional hypothermia and the development of postoperative delayed neurologic dysfunction." - Anonymous Online Contributor

Unverified Answer

What causes perioperative tissue oxygenation?

"The perioperative oxygen partial pressure is determined by the rate of oxygen consumption and by the supply of oxygen to the tissue. The rate of oxygen consumption, related to metabolic demands with no alteration of oxygen transport, is a very important factor determining the partial pressure." - Anonymous Online Contributor

Unverified Answer

What are the signs of perioperative tissue oxygenation?

"Muscle blood flow limitation is the first and only clinical sign of tissue oxygenation and recovery. Changes in blood flow are most profound in muscle and subcutaneous tissue." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of perioperative tissue oxygenation?

"There was a strong correlation between the change in pHi and the change in MAP that occurred within 30 min postoperatively at the site(s) of measurement in patients undergoing major surgical procedures. The change in pHi correlated strongly with MAPs, indicating that pHi is a marker of MAP and therefore most likely a measure of tissue oxygenation. These data refute the primary source of pHi increases as being vasomotor or reactive changes in peripheral blood flow to the operative site." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for perioperative tissue oxygenation?

"The criteria for considering a trial have been refined in recent years. The best way to determine the value of the treatment is a well-designed trial using an intent to treat model." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of dobutamine?

"There are potentially more serious side effects from dobutamine as compared to other sympathomimetic drugs and, if used routinely, a large proportion of patients can be overlooked. However, a wide range of benign side effects occurs following all forms of sympathetic stimulation." - Anonymous Online Contributor

Unverified Answer

What is the latest research for perioperative tissue oxygenation?

"In recent years, the role of PTT measurements in perioperative management is being increasingly validated with some evidence suggesting that monitoring may lead to enhanced clinical outcomes in some patients. It is important to acknowledge a growing body of evidence demonstrating the utility of PTT measurement and its place alongside NIRS monitoring in the perioperative management of patients undergoing an elective procedure that requires CPB." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets perioperative tissue oxygenation?

"There is a lack of consensus regarding the average age people with cancer can receive perioperative treatment with PTO. Because these treatments are not commonly discussed with patients and the average age we give is lower than most providers believe, there is an opportunity for educating patients and the general public about this common procedure and its potential benefits. A randomized clinical trial should evaluate treatment of higher-risk patients who need PTO before general surgery." - Anonymous Online Contributor

Unverified Answer

How does dobutamine work?

"Administration of intravenous dobutamine before cardiopulmonary bypass decreased cardiac output and provided no extra benefit beyond that afforded by epinephrine alone. By comparison, preload was preserved during dobutamine administration at the dose (3 micrograms/kg/min) used in this study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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