Primary objective:Does perioperative maintenance of cardiac output and pulse pressure variation result in an overall reduction in postoperative complications when compared to arterial blood pressure-guided perioperative hemodynamics in patients…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoints: The primary endpoint is defined as postoperative
morbidity based on the incidence of a number of predefined complications until
30 days after surgery. These parameters include, among others, reoperation,
infections, rehabilitation and restoration of gastrointestinal function.
Secondary outcome
Secondary endpoints include hospital length of stay and microcirculatory
perfusion.
Background summary
This investigation is based on the hypothesis that perioperative guidance of
global tissue perfusion and volemic state by cardiac output and pulse pressure
variation is associated with less postoperative complications than arterial
blood pressure-guided therapy in patients undergoing abdominal surgery. In the
present study we therefore aim to compare these two strategies of perioperative
hemodynamic optimization to evaluate the effects of both strategies on patient
outcome.
Study objective
Primary objective:
Does perioperative maintenance of cardiac output and pulse pressure variation
result in an overall reduction in postoperative complications when compared to
arterial blood pressure-guided perioperative hemodynamics in patients
undergoing elective abdominal surgery?
Secondary objectives:
Does perioperative maintenance of cardiac output and pulse pressure variation
result in distinct perioperative microcirculatory perfusion patterns when
compared to arterial blood pressure-guided perioperative hemodynamics in
control patients?
What is the level of agreement between Nexfin and Flotrac arterial blood
pressure, cardiac output and PPV.
Study design
Multicenter, single-blinded randomized clinical intervention trial.
Intervention
Intervention: Hemodynamic guidance based on arterial blood pressure or cardiac
output with pulse pressure variation.
Study burden and risks
This investigation is associated with a minimal risk for the patient. Most
procedures will be performed during general anesthesia and do not divert from
routine clinical practice. Only in the 15 minutes before anesthesia induction
patients are aware of the finger cuff device and arterial line for arterial
blood pressure, cardiac output and pulse pressure variation measurements.
Perioperative arterial blood pressure (control A) or cardiac output and pulse
pressure variation (CO group)-guided therapy by fluids and/or vasopressors will
not divert from standard clinical care. Patients will be phoned at 7 and 30
days after surgery. Thirty days after surgery, patients receive a questionnaire
to identify postoperative complications and rehabilitation.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing elective abdominal surgery
Age 18-85 years
Exptected duration of surgery > 90 minutes
Informed consent
Exclusion criteria
Preexisting cardiac arrhythmias
Emergency operation
ICU patients
Body mass index below 20 kg/m2 and above 40 kg/m2.
Patients without an invasive arterial line
Decompensatio cordis
Aortic valve disease
Ejection fraction < 0.3
Aortic valve stenosis: surface < 1.2 cm2
Pulmonary arterial pressure > 30 mm Hg, TAPSE < 18 mm
Incapacitated patients
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 |
|---|---|
| CCMO | NL37830.029.11 |