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

Pontificia Universidad Catolica de Chile

Status: Completed

Conditions: Septic Shock

Treatments: Drug: Placebo; Drug: Dobutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01271153

1100610

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Dobutamine

Active Comparator group

Description:

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

Treatment:

Drug: Dobutamine

Placebo

Placebo Comparator group

Description:

An equivalent infusion of placebo will be infused for 2.5 h

Treatment:

Drug: Placebo