Clinical trial NCT01271153: Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients
Official title: Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: Septic shock
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Change in the perfused vascular density
timeFrame: 2.5 h
Secondary outcomes:
measure: Macrohemodynamics
timeFrame: 2.5 h
measure: Transthoracic echocardiography
timeFrame: 2.5 h
measure: Gastric mucosal perfusion
timeFrame: 2.5 h
measure: Hepatosplanchnic blood flow
timeFrame: 2.5 h
measure: Peripheral perfusion
timeFrame: 2.5 h
measure: Metabolic perfusion assessment
timeFrame: 2.5 h
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Universidad Catolica de Chile
state: RM
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Glenn Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernandez G, Regueira T, Bruhn A, Castro R, Rovegno M, Fuentealba A, Veas E, Berrutti D, Florez J, Kattan E, Martin C, Ince C. Relationship of systemic, hepatosplanchnic, and microcirculatory perfusion parameters with 6-hour lactate clearance in hyperdynamic septic shock patients: an acute, clinical-physiological, pilot study. Ann Intensive Care. 2012 Oct 15;2(1):44. doi: 10.1186/2110-5820-2-44.