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NCT Number: NCT01271153

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

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico Universidad Catolica de Chile

Santiago, RM, 6510260, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dobutamine

Drug

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.

Other names: Dobutrex

Placebo

Drug

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.

Other names: Dextrose 5%

Primary outcomes

  1. Change in the perfused vascular density

    Time frame: 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 outcomes

  1. Macrohemodynamics

    Time frame: 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)

  2. Transthoracic echocardiography

    Time frame: 2.5 h

    • Morphology and diameters of cardiac cavities
    • Left ventricular systolic function
    • Right ventricular systolic function
    • left ventricular diastolic function

  3. Gastric mucosal perfusion

    Time frame: 2.5 h

    Gastric mucosal perfusion: gastric air tonometry will be used to measure intraluminal pCO2 and calculate gastric - arterial pCO2 gradient (Tonocap, Datex)

  4. Hepatosplanchnic blood flow

    Time frame: 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).

  5. Peripheral perfusion

    Time frame: 2.5 h

    • 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.)

  6. Metabolic perfusion assessment

    Time frame: 2.5 h

    We will measure mixed venous O2 saturation and arterial lactate

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2011
Registry last updated
Jun 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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