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Lung Injury clinical trials

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NCT ID: NCT01532024 Completed - Acute Lung Injury Clinical Trials

Exploratory Clinical Study of Neutrophil Activation Probe (NAP) for Optical Molecular Imaging in Human Lungs

NAP
Start date: October 2014
Phase: Early Phase 1
Study type: Interventional

Seriously ill patients may develop a complication called acute lung injury (ALI), a form of inflammation in which lung tissue is filled by fluid containing white blood cells called neutrophils. ALI is common and is often fatal (for example in the USA it is estimated that 190,000 patients develop ALI per annum, of whom 75,000 die). No pharmacological treatment has been shown to improve ALI. Data from animal models and patients strongly suggest that neutrophils are central to disease progression. However no bedside methods exist to rapidly and accurately determine in seriously ill patients, if neutrophils are present and if they are releasing damaging enzymes such as elastase. As such, the investigating team have developed and synthesised to clinical grade, an imaging agent called NAP (Neutrophil Activation Probe) that detects activated neutrophils and also the damaging enzyme, human neutrophil elastase (HNE). The investigators have extensively tested NAP in animal models for efficacy and safety. It reliably detects activated neutrophils and is not toxic. NAP is a small molecule that is delivered in tiny doses (called microdoses) to areas of inflammation in human lungs through a bronchoscope. The activity of NAP is visualised by imaging though a tiny camera that is also introduced through the bronchoscope. This camera system is now widely used throughout the world in over 150 sites. The investigators therefore aim to test the utility and safety of NAP in an exploratory clinical study. The study involves the delivery of NAP to 6 healthy volunteers followed by delivering NAP to 3 patients in ICU with pulmonary infiltrates and 6 patients known to have bronchiectasis. In the healthy volunteers study, healthy male volunteers recruited from the University of Edinburgh will be invited to participate. In the ICU study, patients will be recruited from the ICU in the Royal Infirmary of Edinburgh. In the bronchiectasis study, patients will be recruited from the respiratory service in NHS Lothian. If the study (which is supported by the Medical Research Council) demonstrates safety and also the ability to image activated neutrophils, the investigators intention is to design future studies in patients with ALI.

NCT ID: NCT01514331 Completed - Clinical trials for Ventilator Induced Lung Injury

Ventilatory Parameters and Inflammatory Responses of Neonates Ventilated by Different Modes of Ventilation

Start date: January 2012
Phase: N/A
Study type: Interventional

The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in neonates.

NCT ID: NCT01513018 Completed - Clinical trials for Postoperative Lung Injury

Effects of High and Low Tidal Volumes on Arterial Oxygenation and Pulmonary Shunt During One-Lung Ventilation

Start date: June 2009
Phase: N/A
Study type: Interventional

The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during OLV. One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During the subsequent 30 minutes, each patient received the alternative management. Minute volume was thus kept constant during each experimental condition. Arterial blood partial pressures, hemodynamic responses, and ventilatory parameters were recorded. Results are presented as means ± SDs; P < 0.05 was considered statistically significant.

NCT ID: NCT01486342 Completed - Acute Lung Injury Clinical Trials

PET Imaging in Patients at Risk for Acute Lung Injury

PET-ALI
Start date: October 2011
Phase: N/A
Study type: Observational

Despite decades of research, the mortality in acute lung injury remains very high and treatment options are very limited. Given these facts, the best treatment modality may be in prevention of this lethal syndrome. Historically, imaging has played a crucial role in understanding ALI. The appearance of chest radiography is one of the consensus criteria in defining ALI, and commuted tomography (CT) scans further advanced the understanding of the pathoanatomy of ALI. While valuable, these imaging modalities are nonspecific and do not incorporate functional cellular physiology. PET imaging measures concentrations of radioisotopes in the body. By embedding in, but not altering molecules, the natural fate of these tracers can be studied with PET imaging. Advances in the understanding of ALI include blood flow distribution, as well as the response to alveolar recruitment maneuvers and prone positioning. Not all patients who are receiving mechanical ventilation develop ALI. Inflammation in the lungs is known to play a key early role in the development and progression of ALI. Secondary to inflammation, the lungs develop edema and do not exchange oxygen as well. This early inflammation is in part driven by a specific type of immune cell called the neutrophil. These cells seem to travel and become sequestered in the lung- they are "recruited" to the lung during this inflammatory stage. When there, these neutrophils release inflammatory substances which are integral in the development of ALI. Neutrophils use primarily glucose as a fuel source. The radio isotope [18F]Fluorodeoxyglucose (FDG)is a glucose analog and therefore taken up/ingested by the neutrophils as a part of their normal metabolism. Because of this fact, positron emission tomography (PET) using the radio isotope [18F]FDG is a highly sensitive marker to look at the recruitment of neutrophils to the lung, therefore quantifying the degree of pulmonary inflammation prior to the development of ALI. The investigators seek to examine the relationship of pulmonary inflammation in patients at risk for ALI, but without clinical evidence of the syndrome. The investigators seek to enroll ten patients in a pilot trial.

NCT ID: NCT01474863 Completed - Severe Sepsis Clinical Trials

Citrulline in Severe Sepsis

Start date: August 2012
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis is that intravenous L-citrulline will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.

NCT ID: NCT01438853 Completed - Sepsis Clinical Trials

Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome

Start date: December 2004
Phase: Phase 1
Study type: Interventional

This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15 minutes. Three cohorts of subjects were enrolled to the study and safety and pharmacokinetics of the study treatment were evaluated.

NCT ID: NCT01434121 Completed - Sepsis Clinical Trials

Ascorbic Acid (Vitamin C) Infusion in Human Sepsis

Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The major goal of this project is to determine whether intravenously infused ascorbic acid is safe for use as a viable therapeutic strategy in adult humans with sepsis.

NCT ID: NCT01427621 Completed - Clinical trials for Heart Valve Diseases

Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery

Start date: March 2010
Phase: Phase 4
Study type: Interventional

Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the postoperative course of the patients. The investigators hypothesized that RIPCcom, combined intervention of remote ischemic preconditioning and remote ischemic postconditioning, would confer beneficial influence on inflammatory response and resultant postoperative pulmonary dysfunction after CPB in patients undergoing complex valvular heart surgery who are at increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients undergoing complex valvular heart surgery.

NCT ID: NCT01344239 Completed - Clinical trials for Abdominal Aortic Aneurysm

Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair

Start date: January 2008
Phase: N/A
Study type: Interventional

To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.

NCT ID: NCT01335932 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure

GRAIL
Start date: March 10, 2011
Phase: Phase 2
Study type: Interventional

To evaluate whether administration of ganciclovir reduces serum IL-6 levels (i.e. reduction between baseline and 14 days post-randomization) in immunocompetent adults with severe sepsis or trauma associated respiratory failure. Primary Hypotheses: - In CMV seropositive adults with severe sepsis or trauma , pulmonary and systemic CMV reactivation amplifies and perpetuates both lung and systemic inflammation mediated through specific cytokines, and contributes to pulmonary injury and multiorgan system failure, AND - Prevention of CMV reactivation with ganciclovir decreases pulmonary and systemic inflammatory cytokines that are important in the pathogenesis of sepsis and trauma related complications.