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

P

Pontificia Universidad Catolica de Chile

Status

Completed

Conditions

Septic Shock

Treatments

Drug: Placebo
Drug: Dobutamine

Study type

Interventional

Funder types

Other

Identifiers

NCT01271153
1100610

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Dobutamine
Active Comparator group
Description:
Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours
Treatment:
Drug: Dobutamine
Placebo
Placebo Comparator group
Description:
An equivalent infusion of placebo will be infused for 2.5 h
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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