To study the effect of reducing the pulmonary circulation to normal levels on the pulmonary leak index in patients suffering from severe ARDS.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
pulmonary leak index
Secondary outcome
The titrating cardiac index to 2,5 to 3,5 l/min.m2 with a minimal SvO2 of 65%
on ventilator free days, use of rescue therapies and extravascular lung water
index, development of organ failure (SOFA), development of the lung injury
score.
Background summary
It is assumed that acute respiratory distress syndrome (ARDS) is an alveolar
but also an endothelial disorder. Treatment modalities targeting alveolar
disruption focus on low tidal volume ventilation and the avoidance of
atelectasis and successfully decreased mortality. Activated protein C, heparin
inhalation and corticosteroids targeted endothelial inflammation, but these
therapies failed to reduce mortality.
ARDS is often accompanied by sepsis, which is characterized by a high cardiac
output. A high cardiac output might cause endothelial shear stress in the lung,
causing and/or aggravating ARDS. Experimental and retrospective data suggest
that reducing lung capillary flow has a beneficial effect on gas exchange.
Study objective
To study the effect of reducing the pulmonary circulation to normal levels on
the pulmonary leak index in patients suffering from severe ARDS.
Study design
open label, randomized controlled trial
Intervention
Titrating cardiac index to 2,5 -3,5 l/min.m2 with a minimal SvO2 of 65%.
Study burden and risks
Burden to the patient:
An (additional) arterial canule is placed in the femoral artery. Sedated
patients (most of the patients suffering from severe ARDS are deeply sedated)
have minimal burden during placement of this canule. Moreover, this canule can
also function as a routine invasive arterial pressure monitoring tool. Also, it
is possible to withdraw blood from this canule. This makes the standard
invasive canullation superfluous. To measure the pulmonary leak index, a small
amount of radioactive 67Ga will be given. The amount of radiation is considered
minimal.
Risks:
Asthma bronchiale
Bradycardia
hypotension
All patients are admitted on the intensive care unit, in a extensive monitoring
environment. The beta blocker that is used to down regulate cardiac index is
esmolol, known for its very short half-life. If complication occur, beta
blockade therapy is stopped and the complications will resolve.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
severe ARDS with a PaO2/FiO2 ratio < 100 mmHg
Exclusion criteria
patients having increased intracranial pressure
patients on inotropic support
Cardiac index >4 l/min.m2
history of bronchial hyper reactivity
Patients with a preterminal illness (active hematologic disease, metastatic malignancy*s)
Patients below 18 years or older than 85 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37843.078.11 |