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

Primary Purpose

ARDS, Sepsis Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Injection of 1-13 Carbon Leucine and deuterated water
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for ARDS

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Injection of stable isotopes

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Disaturated phosphatidylcholine (DSPC) secretion time
    DSPC 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 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)
    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).
    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).
    Volume of Total Body water
    Measured by the isotope dilution method using deuterium oxide. Total body water will be expressed in liters

    Full Information

    First Posted
    October 31, 2017
    Last Updated
    December 12, 2017
    Sponsor
    University of Padova
    Collaborators
    Città della Speranza, Padova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03371680
    Brief Title
    Kinetics of Surfactant Proteins, Phosphatidylcholine and Body Water in Intensive Care Unit (ICU)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (Actual)
    Primary Completion Date
    December 31, 2013 (Actual)
    Study Completion Date
    December 31, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Padova
    Collaborators
    Città della Speranza, Padova

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ARDS, Sepsis Syndrome

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Injection of stable isotopes
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Injection of 1-13 Carbon Leucine and deuterated water
    Other Intervention Name(s)
    Isotopes came from Cambridge Isotope Laboratories, MA
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Disaturated phosphatidylcholine (DSPC) fractional synthesis rate
    Description
    DSPC deuterium incorporation, change from baseline. The following kinetic parameter will be calculated: fractional synthesis rate (expressed as percentage/day)
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Disaturated phosphatidylcholine (DSPC) secretion time
    Description
    DSPC deuterium incorporation, change from baseline. The following kinetic parameter will be calculated: secretion time (expressed in hours).
    Time Frame
    48 hours
    Title
    Surfactant protein B and Surfactant protein C synthesis rate
    Description
    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
    Title
    Surfactant protein B and Surfactant protein C secretion time
    Description
    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
    Title
    Surfactant protein B and Surfactant protein C half life
    Description
    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
    Title
    Volume of Total Body water
    Description
    Measured by the isotope dilution method using deuterium oxide. Total body water will be expressed in liters
    Time Frame
    10 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    76 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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