Status:
COMPLETED
Kinetics of Surfactant Proteins, Phosphatidylcholine and Body Water in Intensive Care Unit (ICU)
Lead Sponsor:
University of Padova
Collaborating Sponsors:
Città della Speranza, Padova
Conditions:
ARDS
Sepsis Syndrome
Eligibility:
All Genders
18-76 years
Phase:
NA
Brief Summary
Analysis of kinetics of phosphatidylcholine and specific surfactant proteins, total body water and water turnover in patients with acute respiratory distress syndrome (ARDS) and in intensive care unit...
Detailed Description
Patients with adult respiratory distress syndrome (ARDS) have low concentrations of disaturated-phosphatidylcholine and surfactant protein-B and C in bronchoalveolar lavage fluid and altered fluid met...
Eligibility Criteria
Inclusion
- Inclusion criteria were:
- adult patients older than 18 years
- expected intensive care unit (ICU) length of stay greater than 120 hours from the onset of acute respiratory failure, defined according to the acute respiratory syndrome (ARDS) Berlin criteria or patients admitted for acute neurological failure defined as Glasgow coma scale \< 8.
- All patients with ARDS also had sepsis syndrome or septic shock according to the surviving sepsis campaign criteria at the admission to the ICU, while no patients with acute neurological failure was septic.
- At the start of the study, patients with ARDS/sepsis fulfilled also the following criteria:
- start of the study within 72 hours from the onset of the respiratory failure;
- stable hemodynamic conditions, defined as no need of fluid boluses for at least 6 hours before the start of the study;
- serum urea and creatinine within the normal ranges.
- Patients with acute neurological failure fulfilled the following inclusion criteria:
- normal chest radiograph;
- arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2/FiO2) \>300;
- no evidence of sepsis, according to body temperature, C reactive protein, white cell count and differential count within normal ranges;
- intubation and mechanical ventilation started within 72 h before the beginning of the study.
Exclusion
- Exclusion criteria for all study subjects were:
- presence of liver failure or renal failure (transaminases \> 3 and creatinine \> 2 times the normal values),
- burns \> 30% of body surface bone marrow or lung transplantation,
- need of fluid boluses to maintain hemodynamic conditions during the study or extracorporeal circulatory support.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03371680
Start Date
October 1 2010
End Date
December 31 2013
Last Update
December 13 2017
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