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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30367

Enrollment

120

Registered

2006-12-08

Start date

2005-09-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haemodynamic monitoring in sepsis and cardiovascular surgery

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Age 80 years Pregnancy Pre-terminal illness with life expectancy

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Netherlands

Outcome results