Main objective is to study changes in in vivo blood viscosity during mild therapeutic hypothermia and rewarming in patients after cardiac arrest. Secondary objectives are to study the effects of cooling and rewarming on-Hemodynamic parameters-…
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Condition
- Other condition
- Neurological disorders NEC
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Health condition
bloedruk en orgaandoorbloeding na hartstilstand
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint is the change in blood viscosity in time during hypothermia
and subsequent rewarming.
Secondary outcome
Secondary study parameters are
- Hemodynamic changes, such as heart rate, blood pressure, cardiac output,
central venous pressure, pulse pressure variation (PPV), stroke volume, stroke
volume variation (SVV), systemic vascular resistance (SVR), global
end-diastolic volume, intrathoracic blood volume, and extravascular lung water
during hypothermia and rewarming.
- Changes in parameters of cardiac compliance during hypothermia and rewarming.
- Changes in cerebral, renal and splanchnic blood flow during hypothermia and
rewarming.
- Changes in cerebral autoregulation during hypothermia and rewarming.
- Effect of fluid resuscitation on hemodynamic parameters and whole blood
viscosity during hypothermia and rewarming.
Background summary
The prognosis of patients after cardiac arrest is poor. Hypotension in the
postresuscitation phase is associated with an increased mortality and a greater
than 3fold increased odds of in-hospital death. Primary aim of the ICU
treatment after cardiac arrest is prevention of secondary organ damage by
ensuring adequate blood flow and oxygenation of all organs. Little is known
about the effects of hypothermia on blood pressure and organ blood flow. Organ
blood flow is dependent on blood flow, perfusion pressure and viscosity of
whole blood. Hypothermia may change the flow properties of blood, thus
influencing oxygenation of organs. Most organs are protected against changes in
organ blood flow through the mechanism of autoregulation. Autoregulation may be
disturbed after cardiac arrest. The effects of hypothermia on autoregulation is
unknown
Study objective
Main objective is to study changes in in vivo blood viscosity during mild
therapeutic hypothermia and rewarming in patients after cardiac arrest.
Secondary objectives are to study the effects of cooling and rewarming on
-Hemodynamic parameters
-changes in cardiac compliance
- Fluid resuscitation
-cerebral autoregulation
-blood flow through organs such as brain, gastrointestinal tract and kidney
Study design
Observational study.
Study burden and risks
The study will be performed in incapacitated patients, since hypothermia is
only indicated in comatose patients that are (by definition) at least
temporarily incapacitated. The study is largely observational in nature, using
measurements and techniques that are routinely used in these critically ill
patients. The study will be completed during the stay in the ICU, and does not
require additional visits to the hospital. Measurement of organ blood flow,
such as cerebral and renal blood flow is done with a non-invasive technique,
without risk or burden to the patient. A gastric tonometry catheter will be
used instead of a standard gastric feeding tube. This tube has the same
properties as standard tubes and does not require replacement by a standard
tube after completion of the study. The central venous catheter used for in
vivo measurement of viscosity has the same properties compared to standard
venous (Arrow®) catheters. Insertion and use of this catheter will not lead to
additional risks compared to a standard catheter. After completion of the
experiments this catheter will be used as a standard central venous catheter.
Fluid resuscitation in patients after cardiac arrest is part of standard care.
Before and after administration of a fluid bolus, additional hemodynamic and
viscosity measurements will be performed, mostly as part of routine intensive
care. Taken together, the risk and burden associated with participation to this
study are minimal. Participation will not directly be beneficial for the
individual patient, but will enable the investigators to learn more about the
effects of hypothermia on hemodynamic characteristics and organ perfusion.
POstbus 9101
6500 HB Nijmegen
NL
POstbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Informed consent
- Age >= 18 years
- Out of hospital cardiac arrest
- Initial rhythm on arrival of the ambulance ventricular fibrillation or non-perfusion ventricular tachycardia or a presumed cardiac origin of the arrest
- Glasgow coma score upon arrival at the hospital of 8 or less
- Indication for mild therapeutic hypothermia
Exclusion criteria
- Comatose state before cardiac arrest or known neurological disease
- Cardiogenic shock, defined as mean arterial pressure less than 60 mmHg and/or urine production < 0.5 ml/kg bodyweight/hour, despite use of inotropic agents
- Hypoxemia, defined as oxygen saturation in arterial blood < 85%
- Chronic renal failure (creatinine > 200 µmol/ml), chronic liver failure
- Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL23118.091.09 |