Comparison of pressure- and volume-guided fluid management in the critically ill: the PAC-PiCCO trial.

Phase 4

Conditions: haemodynamic monitoring in sepsis and cardiovascular surgery
10019280
10002252

Registration Number: NL-OMON30367

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 120

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measures will be ventilator-free days (from inclusion to<br /><br>extubation, with inclusion of re-intubation and ventilator days) in the ICU and<br /><br>length of stay in the ICU and the hospital (until day 28). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measurements will be:<br /><br>1. Hemodynamic measurements, extra-vascular lung water (EVLW), daily fluid<br /><br>balance, during first 72 h after inclusion (and in the subsequent 72 h when<br /><br>monitoring is again clinically indicated)<br /><br>2. Daily LIS and organ failure (SOFA, see appendix I), which can be deducted<br /><br>from routine clinical and laboratory values obtained on a daily basis in<br /><br>critically ill patients, during the first 72 h after inclusion (and the<br /><br>subsequent 72 H when monitoring is again clinically indicated)<br /><br>3. Development of ARDS (see appendix I), until day 28<br /><br>4. Complications associated with the catheter insertion procedure (both<br /><br>immediate, eg arterial puncture, bleeding or pneumothorax, and delayed,<br /><br>pneumothorax within 24 days).<br /><br>5. ICU mortality and hospital mortality (until day 28)</p><br>