Skip to content

Kinetics of Surfactant Proteins, Phosphatidylcholine and Body Water in Intensive Care Unit (ICU)

Kinetics of Disaturated-phosphatidylcholine and Specific Surfactant Proteins Turnover, Water Turnover and Total Body Water in Acute Respiratory Distress Syndrome (ARDS) in Intensive Care Unit (ICU) Patients and in Control Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03371680
Enrollment
21
Registered
2017-12-13
Start date
2010-10-31
Completion date
2013-12-31
Last updated
2017-12-13

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

Conditions

ARDS, Sepsis Syndrome

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 (ICU) patients by using non radioactive isotopes as deuterium and Carbon-13.

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 metabolism. Injection of stable isotopes such as 13 Carbon Leucine and deuterated water allows the analysis of disaturated-phosphatidylcholine and surfactant protein-B and C kinetics, total body water and water turnover in patients with ARDS and in human adults with normal lungs (controls).

Interventions

DRUGInjection of 1-13 Carbon Leucine and deuterated water

All patients received a constant intravenous infusion of 1 g 1-13 Carbon Leucine (Cambridge Isotope Laboratories, Andover, MA) dissolved in saline for 24 h. Deuterated water (Cambridge Isotope Laboratories, Andover, MA) was administered as a 25 ml bolus at the study start and then, every 12 hours over the next 36 hours, as intermittent boluses corresponding to 0.0625% of fluid intake, to maintain steady state of deuterium enrichment in body water

Sponsors

Città della Speranza, Padova
CollaboratorUNKNOWN
University of Padova
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Disaturated phosphatidylcholine (DSPC) fractional synthesis rate48 hoursDSPC deuterium incorporation, change from baseline. The following kinetic parameter will be calculated: fractional synthesis rate (expressed as percentage/day)

Secondary

MeasureTime frameDescription
Disaturated phosphatidylcholine (DSPC) secretion time48 hoursDSPC deuterium incorporation, change from baseline. The following kinetic parameter will be calculated: secretion time (expressed in hours).
Surfactant protein B and Surfactant protein C synthesis rate48 hoursSurfactant protein B and Surfactant protein C 1 -13 Carbon leucine incorporation, change from baseline. The following kinetic parameter will be calculated: fractional synthetic rate (expressed as percentage/day)
Surfactant protein B and Surfactant protein C secretion time48 hoursSurfactant protein B and Surfactant protein C 1 -13 Carbon leucine incorporation, change from baseline. The following kinetic parameter will be calculated: Secretion time (expressed in hours).
Surfactant protein B and Surfactant protein C half life48 hoursSurfactant protein B and Surfactant protein C 1 -13 Carbon leucine incorporation, change from baseline. The following kinetic parameter will be calculated: half life (expressed in hours).
Volume of Total Body water10 hoursMeasured by the isotope dilution method using deuterium oxide. Total body water will be expressed in liters

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026