Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients
Primary Purpose
Septic Shock
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Dobutamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Septic shock
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
Sites / Locations
- Hospital Clinico Universidad Catolica de Chile
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dobutamine
Placebo
Arm Description
Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours
An equivalent infusion of placebo will be infused for 2.5 h
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Macrohemodynamics
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
Morphology and diameters of cardiac cavities
Left ventricular systolic function
Right ventricular systolic function
left ventricular diastolic function
Gastric mucosal perfusion
Gastric mucosal perfusion: gastric air tonometry will be used to measure intraluminal pCO2 and calculate gastric - arterial pCO2 gradient (Tonocap, Datex)
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).
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.)
Metabolic perfusion assessment
We will measure mixed venous O2 saturation and arterial lactate
Full Information
NCT ID
NCT01271153
First Posted
January 5, 2011
Last Updated
June 25, 2015
Sponsor
Pontificia Universidad Catolica de Chile
1. Study Identification
Unique Protocol Identification Number
NCT01271153
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Septic shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dobutamine
Arm Type
Active Comparator
Arm Description
Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An equivalent infusion of placebo will be infused for 2.5 h
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Other Intervention Name(s)
Dobutrex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dextrose 5%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the perfused vascular density
Description
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).
Time Frame
2.5 h
Secondary Outcome Measure Information:
Title
Macrohemodynamics
Description
Macrohemodynamic values: mean arterial pressure, heart rate, and pulmonary artery catheter derived values (pulmonary artery occlusion pressure, cardiac index, systemic vascular resistance index)
Time Frame
2.5 h
Title
Transthoracic echocardiography
Description
Morphology and diameters of cardiac cavities
Left ventricular systolic function
Right ventricular systolic function
left ventricular diastolic function
Time Frame
2.5 h
Title
Gastric mucosal perfusion
Description
Gastric mucosal perfusion: gastric air tonometry will be used to measure intraluminal pCO2 and calculate gastric - arterial pCO2 gradient (Tonocap, Datex)
Time Frame
2.5 h
Title
Hepatosplanchnic blood flow
Description
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).
Time Frame
2.5 h
Title
Peripheral perfusion
Description
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.)
Time Frame
2.5 h
Title
Metabolic perfusion assessment
Description
We will measure mixed venous O2 saturation and arterial lactate
Time Frame
2.5 h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Hernandez, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico Universidad Catolica de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
6510260
Country
Chile
12. IPD Sharing Statement
Citations:
PubMed Identifier
23067578
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.
Results Reference
derived
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Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients
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