Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-01-31

Brief Summary

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The investigators hypothesize that dobutamine is able to revert negative redistribution of flow by inducing a selective vasodilatory effect on hypoperfused territories, particularly at the sublingual and gastric mucosa, and at the peripheral tissues.

The investigators designed a randomized, cross-over, placebo-controlled study looking at the acute physiologic effects of 5 mcg/kg/min fixed-dose of dobutamine on cardiac function, microcirculation, gastric mucosal, hepatosplanchnic, and peripheral perfusion in septic shock patients.

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Detailed Description

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The investigators hypothesize that dobutamine is able to revert negative redistribution of flow by inducing a selective vasodilatory effect on hypoperfused territories, particularly at the sublingual and gastric mucosa, and at the peripheral tissues. Therefore, dobutamine improves microcirculatory alterations and regional perfusion in septic shock, independent of its effects on cardiac output.

The relevance of this concept is that it would support a more rational use of dobutamine in septic shock patients, not only as an inotrope to increase cardiac output, but more important, as a selective vasodilator aimed at restoring perfusion.

Therefore, the investigators designed a randomized, cross-over, placebo-controlled study looking at the acute physiologic effects of 5 mcg/kg/min fixed-dose of dobutamine on cardiac function, microcirculation, gastric mucosal, hepatosplanchnic, and peripheral perfusion in septic shock patients.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dobutamine

Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours

Group Type ACTIVE_COMPARATOR

Dobutamine

Intervention Type DRUG

Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours each. Measurements will be performed at baseline (within 30 minutes before starting the infusion) and repeated within the last 30 minutes of drug infusion.

Placebo

An equivalent infusion of placebo will be infused for 2.5 h

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A 5% dextrose solution will be administered for 2.5 hours. Measurements will be performed at baseline (within 30 minutes before starting the infusion) and repeated within the last 30 minutes of drug infusion.

Interventions

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Dobutamine

Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours each. Measurements will be performed at baseline (within 30 minutes before starting the infusion) and repeated within the last 30 minutes of drug infusion.

Intervention Type DRUG

Placebo

A 5% dextrose solution will be administered for 2.5 hours. Measurements will be performed at baseline (within 30 minutes before starting the infusion) and repeated within the last 30 minutes of drug infusion.

Intervention Type DRUG

Other Intervention Names

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Dobutrex Dextrose 5%

Eligibility Criteria

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Inclusion Criteria

* Adult patients (\>18 years)
* Septic shock for less than 24 hours
* Arterial lactate \> 2.4 mmol/l
* Mechanical ventilation and pulmonary artery catheter in place

Exclusion Criteria

* Pregnancy
* Refractory hypotension
* Acute coronary syndrome within the last 3 months
* Previous use of dobutamine during the last 72 hours
* Cardiac index \< 2.5 l/min/m2
* Non-sinus rhythm
* Heart rate \>140 BPM
* Anticipated surgery or dialytic procedure during the study period
* Child B or C liver cirrhosis
* Hemoglobin \< 8 gr/dl
* Uncontrollable fever \> 39ºC

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No