To investigate the effects of atrial pacing on right ventricular function and hemodynamics after open heart surgery.
ID
Source
Brief title
Condition
- Myocardial disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
right ventricular ejection fraction (RVEF)
Secondary outcome
cardiac index (CCI)
mean pulmonary arterial pressure (MPAP)
central venous pressure (CVP)
mixed venous saturation (SvO2)
right ventricular enddiastolic volume index (EDVI)
right ventricular stroke volume index (RVSVI)
right ventricular stroke work index (RVSWI)
left ventricular stroke work index (LVSWI)
systolic, diastolic and mean arterial pressure (MAP).
Background summary
Temporary pacing with an external pacemaker after open heart surgery * besides
preventing arrhythmias and AV-conduction disorders * is used to improve cardiac
output. In theory, postoperative stunning temporarily limits stroke volume and
SA-node dysfunction compromises an adequate compensatory rise in heartrate to
ensure sufficient cardiac output. There is a lack of consensus regarding the
use of this form of pacing. Protocols vary widely between hospitals. Moreover,
the scientific base for this form of pacing mainly comprises studies dating
back to the nineteen sixties and seventies. Major changes in (operating)
techniques have taken place since then. Also, the role of the right ventricle
in this context has not been studied specifically. The current study aims to
investigate the effects of atrial pacing on right ventricular function
specifically and hemodynamics in general, in today*s postoperative setting. We
hypothesize that a reduction in heart rate may lead to decreased right
ventricular function.
Study objective
To investigate the effects of atrial pacing on right ventricular function and
hemodynamics after open heart surgery.
Study design
A prospective non-randomized, non-blinded interventional study, in which
patients will act as their own controls.
Intervention
When a hemodynamically stable state is achieved, the external pacemaker will be
switched off for 30 minutes. Hemodynamic parameters will be acquired directly
prior to switching off, 15 respectively 30 minutes after switching off, and 15
minutes after switching back on. To gain insight in the natural course of
stunning, this routine will be repeated the next morning. No additional
hemodynamic interventions will be allowed in these periods.
Study burden and risks
The study population is selected to minimize burden and risks. All required
(measuring-) equipment is part of the standard perioperative protocol. The only
additions will be the intervention itself (two periods without pacing). During
the first period patients will still be sedated, so it will not consciously
affect them. During the second period patients may experience dizziness due to
bradycardia. For safety reasons the intervention will be terminated in case of
development of hypotension (MAP < 60 mmHg). Length of stay in the intensive
care unit will not be negatively affected. Study subjects do not directly
benefit form this study, however, they will contribute to possible improvement
in treatment of future patients. .
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
- Age * 18 years old
- Post open on-pump cardiac surgery
- Swan Ganz catheter in situ
- Hemodynamic stability (optimal rescusitation; expected no-touch period of 45 minutes)
- Atrial pacing
Exclusion criteria
- Hypotension (MAP < 60 mmHg)
- Active bleeding ((* 200 cc/hour)
- Atrial malsensing/malpacing
- Ventricular or DDD-paced rythm
- Atrial fibrillation
- AV-conduction dysorders (2nd or 3rd grade AV-blocks)
- Sinusrythm * 80 beats/min (hemodynamic effects of increasing heartrate to 90 beats/min will probably be limited)
- Presence of internal pacemaker
- Severe tricuspid valve regugitation
- Intracardiac shunt (unreliable Swan Ganz measurements)
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 | NL68550.099.19 |