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

Condition(s) targeted: Septic Shock

Intervention: Dobutamine (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pontificia Universidad Catolica de Chile

Official(s) and/or principal investigator(s):
Glenn Hernandez, MD, Principal Investigator, Affiliation: Pontificia Universidad Catolica de Chile

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.

Official title: Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in the perfused vascular density

Secondary outcome:

Macrohemodynamics

Transthoracic echocardiography

Gastric mucosal perfusion

Hepatosplanchnic blood flow

Peripheral perfusion

Metabolic perfusion assessment

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Hospital Clinico Universidad Catolica de Chile, Santiago, RM 6510260, Chile

Starting date: August 2010
Last updated: June 25, 2015