a) to study if biochemical evidence of myocardial injury is associated with impaired myocardial function and to study potential determinants, and b) to study if impaired myocardial function is associated with the need for vaso-active support
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Haemodynamic indices of myocardial dysfunction (cardiac index, global ejection
fraction, dPmax).
Secondary outcome
Need for vaso-active infusions (dopamine, dobutamine, norepinephrine)
Background summary
Mechanical ventilation of patients with respiratory failure has added
significantly to the survival. Over the last years it has become apparent that
mechanical ventilation itself induces pulmonary inflammation, termed ventilator
induced lung injury (VILI). VILI has been linked to multiple organ dysfunction
syndrome (MODS). The heart is one of the organs involved in MODS in patients
with ALI/ARDS. Biochemical evidence of myocardial injury in critically ill
mechanically ventilated children has been reported by various groups. However,
the effects on myocardial function as well as the clinical consequences of
these observations remain unclear and need to be studied.
Study objective
a) to study if biochemical evidence of myocardial injury is associated with
impaired myocardial function and to study potential determinants, and b) to
study if impaired myocardial function is associated with the need for
vaso-active support
Study design
Prospective, observational study with invasive measurements.
Intervention
Insertion of central arterial line with option for thermodilution
Study burden and risks
A special arterial line will be inserted into the femoral artery. Blood samples
(2 ml) will be drawn at baseline, 24, 48 en 72 hours after enrolment. At these
same time intervals haemodynamic measurements are performed. Patients are
sedated during their PICU stay and receive proper analgesia. Potential risks
include displacement of the indwelling arterial or central venous catheter, or
haemorrhage at the injection site during insertion of the line.
P.O. Box 30.001
9700 RB Groningen
Nederland
P.O. Box 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Presence of biochemical evidence of myocardial injury (cardiac Troponin T and/or CK-MB and/or NT pro-BNP greater than the upper limit of the reference value)
Mechanical ventilation for at least 24 hours
Presence of indwelling central venous line
Informed consent obtained from parents or legal caretakers
Exclusion criteria
Mechanical ventilation less than 24 hours
History of congenital heart disease
Surgery for congenital heart disease
History of acquired heart disease (i.e. cardiomyopathy, myocarditis)
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 | NL29815.000.10 |