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

NCT ID: NCT03371680

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-12-31

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).

Conditions

ARDS; Sepsis Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Injection of stable isotopes

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

Group Type: EXPERIMENTAL

Injection of 1-13 Carbon Leucine and deuterated water

Intervention Type: 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

Interventions

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

Other Intervention Names

Isotopes came from Cambridge Isotope Laboratories, MA

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Città della Speranza, Padova

UNKNOWN

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1235P

Identifier Type: -

Identifier Source: org_study_id