NCT01271153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

2.4 years

First QC Date

January 5, 2011

Last Update Submit

June 25, 2015

Conditions

Septic Shock

Keywords

Septic shock

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Macrohemodynamics

    2.5 h

  • Transthoracic echocardiography

    2.5 h

  • Gastric mucosal perfusion

    2.5 h

  • Hepatosplanchnic blood flow

    2.5 h

  • Peripheral perfusion

    2.5 h

  • +1 more secondary outcomes

Study Arms (2)

Dobutamine

ACTIVE COMPARATOR

Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours

Drug: Dobutamine

Placebo

PLACEBO COMPARATOR

An equivalent infusion of placebo will be infused for 2.5 h

Drug: Placebo

Interventions

DobutamineDRUG

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.

Also known as: Dobutrex
Dobutamine
PlaceboDRUG

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.

Also known as: Dextrose 5%
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universidad Catolica de Chile

Santiago, RM, 6510260, Chile

Location

Related Publications (1)

  • 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.

    PMID: 23067578DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Dobutamine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

CatecholaminesAminesOrganic ChemicalsPhenethylaminesEthylaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Glenn Hernandez, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

August 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

CL(1)