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

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Drug: Placebo; Drug: Dobutamine

• Registration Number: NCT01271153
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	An equivalent infusion of placebo will be infused for 2.5 h
Dobutamine	Dobutamine	Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours

Primary Outcome Measures

Name	Time	Method
Change in the perfused vascular density	2.5 h	Perfused vessel density is a measure of sublingual microcirculation. It will be assessed with SDF videomicroscopy (Microscan ® for NTSC, Microvision Medical, Amsterdam, NL). (Crit Care 2007; 11:R101).

Secondary Outcome Measures

Name	Time	Method
Hepatosplanchnic blood flow	2.5 h	This will be assessed by the ICG-PDR method. Each patient will receive an ICG finger clip which will be connected to a liver function monitor (LiMon Pulsion Medical Systems, Germany).
Metabolic perfusion assessment	2.5 h	We will measure mixed venous O2 saturation and arterial lactate
Macrohemodynamics	2.5 h	Macrohemodynamic values: mean arterial pressure, heart rate, and pulmonary artery catheter derived values (pulmonary artery occlusion pressure, cardiac index, systemic vascular resistance index)
Transthoracic echocardiography	2.5 h	1. Morphology and diameters of cardiac cavities; 2. Left ventricular systolic function; 3. Right ventricular systolic function; 4. left ventricular diastolic function
Gastric mucosal perfusion	2.5 h	Gastric mucosal perfusion: gastric air tonometry will be used to measure intraluminal pCO2 and calculate gastric - arterial pCO2 gradient (Tonocap, Datex)
Peripheral perfusion	2.5 h	1. Peripheral flow index (PFI), derived from the pulse oxymetry signal (MP20 IntelliVue monitor, Philips Medical systems, Amsterdam,NL); 2. Temperatures at the blood (by PAC), and at different places in the skin. We will calculate central to toe gradient (Tc-toe), and forearm to fingertip skin temperature gradient (Tskin-diff); 3. NIRS: Tissue oxygen saturation (StO2) will be measured by a tissue spectrometer (InSpectra Model 325, Hutchinson Technology, Hutchinson, Minn.)

Trial Locations

Locations (1)

Hospital Clinico Universidad Catolica de Chile; 🇨🇱 Santiago, RM, Chile