To study the effect of ELC during mechanical ventilation (MV) on fluid balance in severe sepsis or septic shock.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cumulative fluid balance over first 3 days.
Secondary outcome
Global hemodynamic parameters (heart rate, blood pressure, central venous
pressure and cardiac output),, vasopressor need, number of ventilator free
days, length of stay in the ICU and in the hospital, and SOFA scores.
Background summary
The management of severe sepsis or septic shock includes extensive fluid
resuscitation, which may lead to tissue oedema in case of overhydration. Our
hypothesis is that the application of intermittent positive pressure on lower
extremities by external leg compression (ELC) increases blood flow to the heart
(preload) and improves hemodynamic stability with less fluid requirement during
the patients* stay in the intensive care unit (ICU).
Study objective
To study the effect of ELC during mechanical ventilation (MV) on fluid balance
in severe sepsis or septic shock.
Study design
Randomized controlled clinical trial in MV patients with severe sepsis or
septic shock in the ICU.
Intervention
The intervention group will receive ELC within 6 hours after intubation and
start of MV. The ELC around the legs will be inflated to a pressure of 50 cmH2O
during inspiration and deflated to a pressure of 10 cmH2O during expiration.
ELC will be applied only during the first 72 hours (3 days) of MV.
Study burden and risks
The stockings are made from non-allergenic garment, and we will apply a maximum
pressure of 50 cmH2O to inflate the ELC during inspiration and this level has
been proven safe in the healthy volunteers. In this study, we will use the
stocking in patients with impaired circulation, which may lead to ulcura or
other severe complications. The complications will be reported via CCMO online
website. In addition, an interim analysis will be done and the study will be
stopped if necessary.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
- Age >18 years, <80 years
- Severe sepsis or sepsis shock
- Mechanically ventilated
- Picco Monitoring
- Written informed consent from legal representatives
Exclusion criteria
- Morbid obese defined as BMI > 35 kg/m2;
- Death appearing imminent at admission (predicted in less than 24 hours)
- Pregnancy
- Injury or trauma of legs
- Burns of surface areas of legs
- Visible ulcers and known peripheral arterial insufficiency of legs;
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 | NL35723.078.11 |