An interventional study of Injection of 1-13 Carbon Leucine and deuterated water in ARDS and Sepsis Syndrome, sponsored by University of Padova. Completed. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by University of Padova · Not applicable, Interventional, and Basic science
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.
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).
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This study's enrollment of 21 is below the median of 76 across 98 interventional studies indexed under Systemic Inflammatory Response Syndrome.
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Inclusion Criteria:
Inclusion criteria were:
At the start of the study, patients with ARDS/sepsis fulfilled also the following criteria:
Patients with acute neurological failure fulfilled the following inclusion criteria:
Exclusion Criteria:
Exclusion criteria for all study subjects were:
Injection 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
Drug: Injection 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
Also known as: Isotopes came from Cambridge Isotope Laboratories, MA
Disaturated phosphatidylcholine (DSPC) fractional synthesis rate
DSPC deuterium incorporation, change from baseline. The following kinetic parameter will be calculated: fractional synthesis rate (expressed as percentage/day)
Time frame: 48 hours
Disaturated phosphatidylcholine (DSPC) secretion time
DSPC deuterium incorporation, change from baseline. The following kinetic parameter will be calculated: secretion time (expressed in hours).
Time frame: 48 hours
Surfactant protein B and Surfactant protein C synthesis rate
Surfactant 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)
Time frame: 48 hours
Surfactant protein B and Surfactant protein C secretion time
Surfactant 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).
Time frame: 48 hours
Surfactant protein B and Surfactant protein C half life
Surfactant 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).
Time frame: 48 hours
Volume of Total Body water
Measured by the isotope dilution method using deuterium oxide. Total body water will be expressed in liters
Time frame: 10 hours
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2010 to primary completion in Dec 2013, 38 months.
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