Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01854424
Other study ID # NI11026
Secondary ID AOM 11005
Status Completed
Phase N/A
First received May 13, 2013
Last updated March 21, 2017
Start date November 2013
Est. completion date July 11, 2016

Study information

Verified date March 2017
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and associated with outcome in different diseases. In previous study, we have demonstrated the presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their association with patient outcome. The purpose of this multicentric observational prospective study is to describe the percentage of alveolar fibrocytes in ICU patients with ARDS (survivors vs. non survivors) and to confirm their association with 28-day mortality.


Description:

Background: The acute respiratory distress syndrome (ARDS) remains common (15% of ventilated patients in the ICU), severe (30% of mortality) and have no specific treatment. Impaired epithelial repair with fibroproliferation is observed in non resolutive form of ARDS. Fibrocytes are cells that both express markers of hematopoietic cells (CD34+, CD45+) and fibroblasts (collagen-1). Fibrocytes may be recruited directly from the pool of circulating blood monocytes but also derive from monocytes in situ in absence of serum amyloid P (SAP or pentraxin-2). In murine models of lung injury, it has been shown that fibrocytes were recruited in the lung and contribute to the local fibrogenesis. Our team is the first to have demonstrated during ARDS in human the presence of fibrocytes among the alveolar cells obtained by bronchoalveolar lavage (BAL) (Quesnel et al, Eur Resp J, 2010). In a second single-center work enrolling 122 patients, we have shown that a percentage of alveolar fibrocytes > 6% was associated with an increased risk of death (HR = 6.2 [2.8 to 13.6], p <0.0001). However, this result remains to be confirmed in a second cohort because it was not the main objective of the first study and because of the variable lead time of BAL sampling in this cohort of patients with ARDS (Quesnel et al, CCM, 2012). Furthermore, the correlation of the percentage of blood fibrocytes (Fsg%) with the percentage of alveolar fibrocytes (Fal%) remains unknown and their kinetics remain to be studied during ARDS evolution.

Hypothesis and Objective: We hypothesize that percentage of alveolar fibrocytes is a prognostic marker during ARDS. Our main goal is to confirm in a validation cohort that the % of alveolar fibrocytes measured in BAL fluid during the first 48 hours of ARDS evolution is associated with 28-day mortality.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date July 11, 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ventilated patients with ARDS criteria as defined by Berlin criteria during the first 48 hours of evolution.

Exclusion Criteria:

- refusal of patient participation, pregnancy, HIV infection, Respiratory insufficiency, Pulmonary fibrosis, cirrhosis (> Child B score), scleroderma, Alzheimer's disease, Bone marrow transplant, chemotherapy-induced aplasia, immunosuppressive therapy, Corticosteroids (> 200 mg/day of hydrocortisone or equivalent in the two weeks preceding inclusion), End of life patient or IGS2 greater than 90, brain death, therapeutic limitation.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution.
All the samples will be obtained during current care in the first week of evolution, and the last set of samples (BAL and blood sample between day 10-14) only in patients still under ventilation at this time point.

Locations

Country Name City State
France Hôpital TENON, département d'anesthésie-réanimation Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the percentage of alveolar fibrocytes in survivors vs. non survivors during ARDS Association with 28-day mortality after inclusion alveolar fibrocytes percentage in BALF obtained in the 48 hours following ARDS diagnosis
Secondary To evaluate kinetics of alveolar and circulating fibrocytes between day-1 and day-14 of ARDS evolution number of fibrocytes in BALF and blood samples < day-2, day-3, day 5-7, day 10-14
Secondary To test the prognostic value of the percentage of alveolar fibrocytes during ARDS Correlation between the percentage of alveolar or blood fibrocytes before day-2 and ventilation time (number of days without invasive ventilation between day 1 and day 28) and length of stay with organ failure (SOFA score evolution between day 1 and 28). < day-2
Secondary To evaluate the association between the percentage of alveolar fibrocyte and inflammatory and fibroproliferative markers association between % of alveolar fibrocytes and markers of epithelial injury and fibroproliferation (alveolar and serum IL-8, IL-10, sRAGE, TGF-beta, procollagen III, SAP, CCL18, concentrations) evaluated at day 1, 3, 5-7 and 10-14. < day-2, day 5-7, day 10-14
See also
  Status Clinical Trial Phase
Completed NCT05921656 - Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Withdrawn NCT04288076 - The Brain and Lung Interaction (BALI) Study N/A
Completed NCT03031860 - Semi-quantitative Cough Strength Score (SCSS) N/A
Completed NCT02545621 - A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
Completed NCT02312869 - Local Assessment of Management of Burn Patients N/A
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT01204281 - Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients Phase 4
Terminated NCT01059929 - Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU) Phase 4
Completed NCT00824239 - Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients Phase 3
Completed NCT00529347 - Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern Phase 1
Unknown status NCT00260676 - Protective Ventilatory Strategy in Potential Organ Donors Phase 3
Terminated NCT00205517 - Sedation and Psychopharmacology in Critical Care N/A
Completed NCT03281785 - Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients. N/A
Recruiting NCT04110613 - RCT: Early Feeding After PEG Placement N/A
Completed NCT04410783 - The Emergency Department Sedation Pilot Trial N/A
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A
Completed NCT03930147 - Ventilation With ASV Mode in Children N/A
Recruiting NCT05029167 - REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study) N/A
Recruiting NCT04849039 - Lung Microbiota and VAP Development (PULMIVAP)