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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371680
• Other study ID #: 1235P
• Status: Completed
• Phase: N/A
• First received: October 31, 2017
• Last updated: December 12, 2017
• Start date: October 2010
• Est. completion date: December 31, 2013

Study information

• Verified date: December 2017
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2013
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• ARDS
• Respiratory Distress Syndrome, Adult
• Sepsis
• Sepsis Syndrome
• Syndrome
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Padova	Città della Speranza, Padova

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	48 hours
Secondary	Disaturated phosphatidylcholine (DSPC) secretion time	DSPC deuterium incorporation, change from baseline. The following kinetic parameter will be calculated: secretion time (expressed in hours).	48 hours
Secondary	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)	48 hours
Secondary	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).	48 hours
Secondary	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).	48 hours
Secondary	Volume of Total Body water	Measured by the isotope dilution method using deuterium oxide. Total body water will be expressed in liters	10 hours