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

NCT03371680 | Completed

• 1 other identifier: 1235P
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ARDS; Sepsis Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Disaturated phosphatidylcholine (DSPC) secretion time

  48 hours

• Surfactant protein B and Surfactant protein C synthesis rate

  48 hours

• Surfactant protein B and Surfactant protein C secretion time

  48 hours

• Surfactant protein B and Surfactant protein C half life

  48 hours

• Volume of Total Body water

  10 hours

Study Arms (1)

Injection of stable isotopes

EXPERIMENTAL

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

Interventions

Injection of 1-13 Carbon Leucine and deuterated water DRUG

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

Injection of stable isotopes

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead
• Città della Speranza, Padova: collaborator

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: December 13, 2017
• Study Start: October 1, 2010
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: December 13, 2017

Record last verified: 2017-12