None listed
Conditions
Brief summary
Acute Respiratory Distress Syndrome (ARDS) is a severe form of lung damage that follows a variety of insults, most commonly infection. This is characterized by lung inflammation and flooding of airspaces within the lung by fluid leaking from the blood vessels. Patients with ARDS usually require life support from a breathing machine (ventilator). About 34% of patients suffering from ARDS die despite best care. At any given point about 6% of patients in all Australian ICUs are suffering from this disease. There is growing evidence to suggest that higher salt levels in the blood may have protective effect on lungs in ARDS. Higher salt concentrations in blood have been shown to reduce inflammatory damage to the lungs, less flooding of airspaces and improved function. However, these data are from isolated cell studies or experiments in non-human lungs. There is an urgent need to explore the beneficial effects of high salt concentration in blood in a controlled study in humans. As a first step towards investigating the beneficial effect of a high blood salt concentration, we will randomize 40 patients with ARDS to either receive usual care or usual care with additional treatment to increase the salt concentration in blood. Higher salt concentrations in blood will be achieved by administering fluids with higher salt content and will be maintained up to 7 days. Daily assessments of lung function and severity of illness will be performed along with close monitoring of any adverse effects of high salt concentrations.
Interventions
Administration of intravenous 20% saline to maintain serum sodium between 145 - 150 mmol /l for 7 days in addition to lung protective ventilation (in accordance with LOVS study; JAMA 2008;299:637-45 ie target tidal volumes of 6 mL/kg of predicted body weight, plateau airway pressures not exceeding 30 cm H2O- examined with by recording the tidal volume and plateau pressure every day,) and conservative fluid management therapy (in accordance with the conservative arm of the FACTT trial (N Engl J
Administration of intravenous 20% saline to maintain serum sodium between 145 - 150 mmol /l for 7 days in addition to lung protective ventilation (in accordance with LOVS study; JAMA 2008;299:637-45 ie target tidal volumes of 6 mL/kg of predicted body weight, plateau airway pressures not exceeding 30 cm H2O- examined with by recording the tidal volume and plateau pressure every day,) and conservative fluid management therapy (in accordance with the conservative arm of the FACTT trial (N Engl J Med 2006; 354:2564-2575; with use of frusemide, restriction of fluid boluses aiming for a negative fluid balance- examined by recording the fluid balance every day )
Sponsors
Shailesh Bihari
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ICU Patients more than equal to 16 years of age who are i) intubated, ii) within 48 hours of a diagnosis of ARDS (PaO2/FiO2 less than equal to 200 mmHg, PEEP = 5 cm H2O, bilateral opacities on chest Xray and respiratory failure not fully explained by cardiac failure or fluid overload) with a known respiratory risk factor for ARDS.
Exclusion criteria
Active bronchospasm or a history of significant chronic obstructive airway disease or asthma, moderate and severe traumatic brain injury, the presence of an intracranial pressure monitor, or any medical condition associated with a clinical suspicion of raised intracranial pressure, lack of consent (treating physician or next of kin), inevitable and imminent death, pregnancy,receiving ECMO, invlovement in other prospective clinical studies.
Outcome results
None listed