Clinically hypovolemic critically ill patients Circulatory System Hypovolemia
Conditions
Interventions
A 90 minute filling pressure-guided fluid challenge after randomization of fluid type: normal saline and the colloids gelatine 4%, hydroxyethyl starch 6% and albumin 5%.
At baseline, patient characte
Sponsors
Vrije Universiteit Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant inclusion criteria as of 24/02/2016: 1. Clinically presumed hypovolaemic critically ill patients, defined as a pulmonary capillary wedge pressure (PCWP) below 10 mmHg in the presence of a pulmonary artery catheter and proper wedging or a central venous pressure (CVP) below 8 mmHg at positive end-expiratory pressure (PEEP) =15 cm H2O and below 12 mm Hg when PEEP >15 cm H2O in the presence of a central venous catheter, and a systolic arterial pressure <110 mmHg in the absence of vasopressor therapy. 2. The presence of a pulmonary artery or central venous catheter. Original participant inclusion criteria: 1. Clinically presumed hypovolaemia 2. Presence of a pulmonary artery or central venous catheter
Exclusion criteria
Exclusion criteria: 1. Age >78 years 2. Pregnancy 3. Known anaphylactoid reactions to colloids 4. A life expectancy ofless than 24 h.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures as of 24/02/2016: 1. The change in haemodynamic parameters of various fluid types before and after fluid loading: cardiac output, intrathoracic blood volume and extravascular lung water by the transpulmonary thermal/dye dilution technique 2. The change in pulmonary parameters of various fluid types before and after fluid loading: pulmonary capillary permeability by the pulmonary leak index for Gallium- 67 (67Ga)-labeled transferrin, and lung injury score: calculated based on the level of PEEP, the arterial PO2/FIO2 ratio, total respiratory compliance and the number of quadrants with alveolar consolidations on the chest radiograph Original primary outcome measures: 1. The change in haemodynamic parameters of various fluid types before and after fluid loading using a variety of hemodynamic parameters varying from arterial pressures to global end diastolic volume index. 2. The difference in acid-base balance of various fluid types before and after fluid loading. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The haemodynamic effects of various fluids in septic and non-septic patients. The following secondary outcome measure was removed on 24/02/2016: The difference in acid-base balance between fluid types. | — |
Countries
Netherlands
Outcome results
None listed