To demonstrate differences in RV function by raising the systemic blood pressure with norepinephrine.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is a difference in RV ejection fraction
Secondary outcome
Secondary endpoints are the echocardiographic parameters of RV and LV
contractility, RV end-diastolic pressure, cardiac index, and fluid balance.
Background summary
Right ventricular (RV) dysfunction in cardiac surgery is an independent risk
factor for morbidity and mortality. Raising the systemic blood pressure with
norepinephrine seems to have a positive influence on the function of the right
ventricle in several animal studies. The current study is designed to evaluate
the effect of a higher blood pressure on the RV function in post cardiac
surgery patients.
Study objective
To demonstrate differences in RV function by raising the systemic blood
pressure with norepinephrine.
Study design
randomized controlled trial
Intervention
Intervention:
* Group 1: (N=22): RVEF<20% and MAP<70mmHg. Intervention with norepinephrine to
reach a MAP of 85mmHg for a maximum duration of four hours.
* Group 2: (N=22): RVEF <20% and MAP<70mmHg. Control group: treatment according
to current standards. Hypotensive patients are treated with fluids and/or
vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.
* Group 3: (N=17): RVEF between *20 and <30%. Intervention with norepinephrine
to reach a MAP of 85mmHg for a maximum duration of four hours.
* Group 4: (N=17): RVEF between *20 and <30%. Control group: treatment
according to current standards. Hypotensive patients are treated with fluids
and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg.
Study burden and risks
Norepinephrine will be used to raise the systemic blood pressure to asses our
end-points. Since the use of Norepinephrine falls within therapeutic routine,
the potential risks are low. Furthermore, all patients will undergo
transoesophageal echocardiography in the postoperative setting. The expected
risk and disadvantages are small. Only minor discomfort is expected because all
patients are sedated during the investigation.
Henri Dunantweg 2
Leeuwarden 8901 BR
NL
Henri Dunantweg 2
Leeuwarden 8901 BR
NL
Listed location countries
Age
Inclusion criteria
- age > 18
- sedated patients
- after cardiac surgery
- informed consent
Exclusion criteria
- acute surgery
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 |
---|---|
Other | clinical trial nr volgt |
CCMO | NL67901.099.18 |