The primary hypothesis of our study is that volumetric monitoring will allow for more effective and targeted fluid administration compared to pressure (PAC) monitoring, thereby allowing the attending physician to better optimize fluid infusion…
ID
Source
Brief title
Condition
- Heart failures
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures will be ventilator-free days (from inclusion to
extubation, with inclusion of re-intubation and ventilator days) in the ICU and
length of stay in the ICU and the hospital (until day 28).
Secondary outcome
Secondary outcome measurements will be:
1. Hemodynamic measurements, extra-vascular lung water (EVLW), daily fluid
balance, during first 72 h after inclusion (and in the subsequent 72 h when
monitoring is again clinically indicated)
2. Daily LIS and organ failure (SOFA, see appendix I), which can be deducted
from routine clinical and laboratory values obtained on a daily basis in
critically ill patients, during the first 72 h after inclusion (and the
subsequent 72 H when monitoring is again clinically indicated)
3. Development of ARDS (see appendix I), until day 28
4. Complications associated with the catheter insertion procedure (both
immediate, eg arterial puncture, bleeding or pneumothorax, and delayed,
pneumothorax within 24 days).
5. ICU mortality and hospital mortality (until day 28)
Background summary
The risk for developing ARDS after cardiopulmonary bypass surgery, major
vascular surgery, or multiple trauma has been reported to range from 10% to
30%; in patients with severe sepsis this number may be even higher (1).
Consequently, fluid management is of great importance in these patients;
excessive fluid administration may increase the risk of pulmonary oedema, while
restricting fluids may lead to intravascular volume depletion with hypotension
and, potentially, renal failure and even multiple organ dysfunction. Getting
the balance just right is of the utmost importance in these patients.
Study objective
The primary hypothesis of our study is that volumetric monitoring will allow
for more effective and targeted fluid administration compared to pressure (PAC)
monitoring, thereby allowing the attending physician to better optimize fluid
infusion strategies in the first 72 hours after study inclusion. The hypothesis
is that use of the volumetric (PiCCO) monitoring strategy will limit fluid
overloading and thereby decrease the weaning period and length of stay in the
ICU and the hospital. The null hypothesis is that there is no difference
between volume (PiCCO) and pressure (PAC) monitoring.
Study design
Patients will be randomized for (fluid) management guided by PAC measurements
or PiCCO during for the first 72 hours after inclusion in the study (since the
PAC is routinely removed 72 h after insertion to avoid infections). Colloid
fluids (gelatin or starches) will be given in bolus doses of 250-500 mL per 30
min when clinically indicated (determined by the attending physician based on
clinical parameters and on the PAC or PiCCO data). Clinical reasons for fluid
administration will include (as a guideline): tachycardia; hypotension;
oliguria (<0.5 mL/kg/h); low flow state (cardiac index <2.1 L/min/m2); low
venous hemoglobin saturation (<70 %); peripheral perfusion deficits, either
alone or in combination, at the discretion of the attending physician.
Vasoactive drugs will be administered and dosed on clinical grounds, as
decided by the attending physician, when maximum values for fluid therapy (see
below) have been reached. Reasons to administer vasoactive drugs will include
persistent and fluid-refractory hypotension, impaired tissue oxygen delivery,
lactic acidosis, oliguria and others. After the initial 72 hour period patients
will be treated at the discretion of the attending physicians. Nevertheless,
the patient will receive a PAC of PiCCO monitoring in the course of disease,
for 72 h, as originally randomized, when clinically indicated and pulmonary
oedema can be suspected on the basis of either deterioration, necessitating
treatment changes, of gas exchange, radiography, ventilatory settings (when
still on mechanical ventilation), or combinations. Similar monitoring and
treatment rules as in the first study period will apply.
The hemodynamic monitoring protocol for each arm will include either
PAC-derived pressures or PiCCO-derived volumetric variables for the first 72
hours (and the subsequent 72 h period when monitoring is again clinically
indicated).
Study burden and risks
NA (possibly lower risk of procedural complications in the PiCCO group compared
to the routine procedure (=PA catheter placement), this is one of the questions
to be addressed in this study).
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Invasive mechanical ventilation, regardless of mode and level of support. Presence of a clinical indication for invasive hemodynamic monitoring with filling pressure and cardiac output measurements by PAC. The indication for PA catheterization will be determined and documented by the attending physician. Reasons may include (but are not necessarily limited to): suspected hypovolemic hypotension; shock of unknown origin; prior or concurrent (suspected) cardiac dysfunction; and (impeding) acute renal failure
Exclusion criteria
Age <18 or >80 years
Pregnancy
Pre-terminal illness with life expectancy <24 hours
Inclusion in other trials
Known cardiac or vascular aneurysm
Known pulmonary hypertension (MPAP above 50 mm Hg).
No informed consent (-by proxy).
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 | NL14119.029.06 |