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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271153
• Other study ID #: 1100610
• Status: Completed
• Phase: N/A
• First received: January 5, 2011
• Last updated: June 25, 2015
• Start date: August 2010
• Est. completion date: January 2013

Study information

• Verified date: June 2015
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad Catolica de Chile	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the perfused vascular density	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).	2.5 h	No
Secondary	Macrohemodynamics	Macrohemodynamic values: mean arterial pressure, heart rate, and pulmonary artery catheter derived values (pulmonary artery occlusion pressure, cardiac index, systemic vascular resistance index)	2.5 h	No
Secondary	Transthoracic echocardiography	Morphology and diameters of cardiac cavities; Left ventricular systolic function; Right ventricular systolic function; left ventricular diastolic function	2.5 h	No
Secondary	Gastric mucosal perfusion	Gastric mucosal perfusion: gastric air tonometry will be used to measure intraluminal pCO2 and calculate gastric - arterial pCO2 gradient (Tonocap, Datex)	2.5 h	No
Secondary	Hepatosplanchnic blood flow	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).	2.5 h	No
Secondary	Peripheral perfusion	Peripheral flow index (PFI), derived from the pulse oxymetry signal (MP20 IntelliVue monitor, Philips Medical systems, Amsterdam,NL); 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); NIRS: Tissue oxygen saturation (StO2) will be measured by a tissue spectrometer (InSpectra Model 325, Hutchinson Technology, Hutchinson, Minn.)	2.5 h	No
Secondary	Metabolic perfusion assessment	We will measure mixed venous O2 saturation and arterial lactate	2.5 h	No