We hypothesize that stepwise dose of intravenous infusion of nitroglycerin reverses clinical abnormalities of peripheral circulation in patients with circulatory shock and that this can lead to improvement in survival rate. In addition, we expect…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
circulatory shock
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Capillary refill time (s), skin-difference temperature gradient (0C),
peripheral perfusion index (a.u.), resting peripheral tissue oxygenation (StO2)
values (%), rate of StO2 desaturation (%/min), rate of StO2 recovery (%/s),
sublingual microcirculation parameters [total vessel density (mm/mm2), perfused
vessel density (mm/mm2), and vessel diameters (µm), red blood cell velocity
(µm /sec), proportion of perfused vessels (%), microvascular flow index (a.u.),
and flow heterogeneity (a.u.)], gastric perfusion parameters (gastric mucosa
CO2 and EtCO2 difference).
Secondary outcome
Global hemodynamic parameters: Fluid balance, mean arterial pressure (MAP),
central venous pressure (CVP), central venous oxygen saturation (ScvO2),
cardiac output and stroke volume, blood lactate levels.
Respiratory function: arterial oxygen pressure/inspired oxygen fraction ratio
(PaO2/FiO2 ratio), mechanical ventilation free-days.
Other study parameters: length of ICU stay , Sequential organ failure
assessment score (SOFA), Acute Physiological and Chronic Health Evaluation
score (APACHE II).
Background summary
Recent clinical studies have shown a relationship between abnormalities in
peripheral perfusion and unfavorable outcome in patients with circulatory
shock. Nitroglycerin is effective in restoring alterations in microcirculatory
blood flow. This study is aimed to investigate whether nitroglycerin could
correct the parameters of an abnormal peripheral circulation in resuscitated
circulatory shock patients.
Study objective
We hypothesize that stepwise dose of intravenous infusion of nitroglycerin
reverses clinical abnormalities of peripheral circulation in patients with
circulatory shock and that this can lead to improvement in survival rate. In
addition, we expect that the easy and reliable clinical parameters of
peripheral perfusion can be an effective monitoring approach at the bedside to
titrate the beneficial effects of nitroglycerin on microcirculation in
individual patient with circulatory shock during initial resuscitation.
Study design
The study is a pilot study and is designed as a randomized controlled trial,
single-blinded. The study will be conducted as a single-center study at the
Intensive Care of the Erasmus Medical Center.
Intervention
Patients will be treated according to their randomization group: nitroglycerin
group or to standard (control) therapy. All patients will be treated according
to the protocol for hemodynamic support without nitroglycerin (control group)
or with nitroglycerin (intervention group). The nitroglycerin infusion rate
will be maintained at 2ml/h (33,3 mcg/min), and patient will be reassessed each
hour. In case of poor peripheral perfusion, nitroglycerin infusion rate will be
increased in a stepwise dose until improvement in the peripheral perfusion
parameters or a maximum dose of 16 mg/h is reached.
Study burden and risks
The suspected benefit is that survival rate in the treatment group can be
improved with nitroglycerin therapy guided by changes in peripheral perfusion
parameters. There is no additional risk for patients concerning the
measurements of peripheral perfusion as all the used techniques are noninvasive
and harmless. There is a possible risk that in the treatment group the patients
will have more chances to develop hypotension (MAP <65mmHg). To ensure that
this will not occur, the vasopressor infusion (noradrenaline) will be started
(in case the patient is not already receiving) or increased if MAP decreases
<65mmHg, irrespective of peripheral perfusion parameters.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All consecutive adult patients admitted to the intensive care for circulatory shock resuscitation in whom abnormal peripheral perfusion is still present despite normalization of global hemodynamic parameters are eligible for this study.
Exclusion criteria
Liver failure, severe coagulation disorder, and any neurological insult that could lead to increased intracranial pressure (stroke, subarachnoid haemorrhage, brain trauma injury).
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2013-002189-38-NL |
| CCMO | NL44945.078.13 |