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Acute respiratory distress syndrome and acute lung injury are well defined and readily recognised clinical disorders caused by many clinical insults to the lung or because of predispositions to lung injury. That this process is common in intensive care is well established. The mainstay of treatment for this disorder is provision of excellent supportive care since these patients are critically ill and frequently have coexisting conditions including sepsis and multiple organ failure. Refinements in ventilator and fluid management supported by data from prospective randomised trials have increased the methods available to effectively manage this disorder.

Barriers to executing large-scale randomized controlled trials include costs, complexity, and regulatory requirements. We hypothesized that source document verification (SDV) via remote electronic monitoring is feasible. Five hospitals from two NIH sponsored networks provided remote electronic access to study monitors. We evaluated pre-visit remote SDV compared to traditional on-site SDV using a randomized convenience sample of all study subjects due for a monitoring visit. The number of data values verified and the time to perform remote and on-site SDV was collected. Thirty-two study subjects were randomized to either remote SDV (N=16) or traditional on-site SDV (N=16). Technical capabilities, remote access policies and regulatory requirements varied widely across sites. In the adult network, only 14 of 2965 data values (0.47%) could not be located remotely. In the traditional on-site SDV arm, 3 of 2608 data values (0.12%) required coordinator help. In the pediatric network, all 198 data values in the remote SDV arm and all 183 data values in the on-site SDV arm were located. Although not statistically significant there was a consistent trend for more time consumed per data value (minutes +/- SD): Adult 0.50 +/- 0.17 min vs. 0.39 +/- 0.10 min (two-tailed t-test p=0.11); Pediatric 0.99 +/- 1.07 min vs. 0.56 +/- 0.61 min (p=0.37) and time per case report form: Adult: 4.60 +/- 1.42 min vs. 3.60 +/- 0.96 min (p=0.10); Pediatric: 11.64 +/- 7.54 min vs. 6.07 +/- 3.18 min (p=0.10) using remote SDV. Because each site had different policies, requirements, and technologies, a common approach to assimilating monitors into the access management system could not be implemented. Despite substantial technology differences, more than 99% of data values were successfully monitored remotely. This pilot study demonstrates the feasibility of remote monitoring and the need to develop consistent access policies for remote study monitoring.

Acute kidney injury (AKI) occurs in 2–10% of patients with acetaminophen (APAP) overdose. Elevation in creatinine (SCr) typically occurs 2 to 5 days after ingestion, with a mean peak on day 7, and normalization over a month. However, it remains unclear whether renal impairment occurs without hepatotoxicity. We hypothesized that APAP-associated acute renal failure occurs in patients with and without severe liver dysfunction after APAP overdose. We retrospectively evaluated all patients admitted to the Medical Intensive Care Unit at a tertiary hospital and received acetylcysteine between June 2009 and December 2014. Of the 303 patients meeting these criteria, 139 of these patients received acetylcysteine for APAP overdose. Of these patients, 138 had Model for End-Stage Liver Disease (MELD) Scores on Day 1 of admission. Using a modified MELD (m-MELD) score, only containing total bilirubin and international normalized ratio not the SCr, the median m-MELD score was calculated. Patients with m-MELD scores below the median were compared to those with scores above the median (low m-MELD score <2.9 or high m-MELD score >2.9). Baseline demographics were similar in the two groups with the exception of more hypertension in the low m-MELD group (24 vs 7%; P= .02). Time to admission was shorter in the low m-MELD group (7.9 ± 9.3 vs. 25.7 ± 29.2 hours; P= .001). The mean admission APAP level was 96.9 (±119) μg/mL in the low compared to 52.3 (±85.3) μg/mL in the high m-MELD group (P= .012). Day one SCr (1.2 ± 0.9 vs 2.7 ± 2.2 mg/dL; P< .0001) and change from baseline to highest SCr (0.2 ± 0.3 vs. 2.7 ± 3.3 mg/dL; P< .0001) were both lower in the low m-MELD group compared to the high m-MELD group. In addition, renal failure resolved upon discharge in all 2 patients (3%) with AKI in the low m-MELD group as compared to only 19 patients (44%) in the high m-MELD group. Mean day one SCr, maximum change in SCr, and lack of renal failure resolution were higher in patients with higher m-MELD scores. However, patients with low m-MELD scores presented much earlier than patients with high m-MELD scores and 26% developed AKI.

The pulmonary artery catheter (PAC) remains widely used in acute lung injury (ALI) despite known complications and little evidence of improved short-term mortality. Concurrent with NHLBI ARDS Clinical Trials Network Fluid and Catheters Treatment Trial (FACTT), we conducted a prospectively-defined comparison of healthcare costs and long-term outcomes for care with a PAC vs. central venous catheter (CVC). We explored if use of the PAC in ALI is justified by a beneficial cost-effectiveness profile. We obtained detailed bills for the initial hospitalization. We interviewed survivors using the Health Utilities Index Mark 2 questionnaire at 2, 6, 9 and 12 m to determine quality of life (QOL) and post-discharge resource use. Outcomes beyond 12 m were estimated from federal databases. Incremental costs and outcomes were generated using MonteCarlo simulation. Of 1001 subjects enrolled in FACTT, 774 (86%) were eligible for long-term follow-up and 655 (85%) consented. Hospital costs were similar for the PAC and CVC groups ($96.8k vs. $89.2k, p = 0.38). Post-discharge to 12 m costs were higher for PAC subjects ($61.1k vs. 45.4k, p = 0.03). One-year mortality and QOL among survivors were similar in PAC and CVC groups (mortality: 35.6% vs. 31.9%, p = 0.33; QOL [scale: 0-1]: 0.61 vs. 0.66, p = 0.49). MonteCarlo simulation showed PAC use had a 75.2% probability of being more expensive and less effective (mean cost increase of $14.4k and mean loss of 0.3 quality-adjusted life years (QALYs)) and a 94.2% probability of being higher than the $100k/QALY willingness-to-pay threshold. PAC use increased costs with no patient benefit and thus appears unjustified for routine use in ALI. www.clinicaltrials.gov NCT00234767.

We determined the variability in enteral feeding practices in mechanically ventilated patients in four adult intensive care units of a tertiary-care, referral hospital. Patients who had been mechanically ventilated for at least 48 h and received enteral nutrition were prospectively followed. Fifty-five of 101 consecutive mechanically ventilated patients received enteral nutrition; in 93% of patients, feedings were infused into the stomach. Patients who were cared for in the medical intensive care unit, where a nutritional protocol was operational, received enteral nutrition earlier in their ventilatory course ( P = 0.004) and feedings were advanced to target rates faster ( P = 0.043) than those who received care in other units. The number ( P = 0.243) and duration ( P = 0.668) of interruptions in feeding did not differ by patient location. On average, patients received only 50% to 70% of their targeted caloric goals during the first 6 days of enteral nutrition. Most feeding discontinuations (41%) were secondary to procedures. Gastrointestinal intolerances, including vomiting, aspiration, abdominal distention, and increased gastric residuals, were uncommon despite allowing gastric residuals up to 300 mL. The practice of providing enteral feeds to mechanically ventilated patients varies widely, even within one hospital. A protocol enhanced early initiation of enteral feeds and advancement to target feeding rates but did not alter the number or duration of interruptions in enteral feedings. Procedures represented the most common reason for stopping enteral feeds, and gastrointestinal intolerances (vomiting, aspiration, and increased gastric residuals) caused few feeding interruptions. The gastric route was safe and well tolerated for early enteral feeding in most mechanically ventilated patients.

One of the characteristics of acute lung injury is noncardiogenic pulmonary edema. Arguments have been made for the management of acute lung injury with either a liberal or conservative approach to fluid administration. In this trial, neither approach offered a mortality benefit; there were clinical and physiological benefits to conservative fluid management. Arguments have been made for the management of acute lung injury with either a liberal or conservative approach to fluid administration. In this trial, neither approach offered a mortality benefit; there were clinical and physiological benefits to conservative fluid management. Pulmonary edema resulting from increased capillary permeability, a hallmark of acute lung injury, worsens as intravascular hydrostatic pressure rises and oncotic pressure falls. 1 , 2 Although lung failure alone can be lethal, death in patients with acute lung injury is usually due to the failure of nonpulmonary organs. 1 , 3 The optimal fluid management of acute lung injury is not settled. 4 – 7 The usual practice is wide-ranging, and many practitioners weigh the risks and benefits of strategies of conservative as compared with liberal fluid management. In the conservative approach, fluid intake is restricted and urinary output is increased in an attempt to . . .

Hemodynamic monitoring is a common physiological intervention in patients with acute lung injury. In this randomized, controlled trial in which patient care was dictated by a specific hemodynamic protocol, there was no significant difference in 60-day mortality whether monitoring was performed with a pulmonary-artery catheter or a central venous catheter. Hemodynamic monitoring is a common physiological intervention in patients with acute lung injury. In this trial there was no significant difference in 60-day mortality whether monitoring was performed with a pulmonary-artery catheter or a central venous catheter. The pulmonary-artery catheter (PAC) provides unique hemodynamic data, including the cardiac index and pulmonary-artery–occlusion pressure. People who advocate the use of the PAC note that the clinician's ability to predict intravascular pressure with the use of this catheter is poor 1 – 3 ; central venous pressure, as obtained by means of the PAC, correlates imperfectly with pulmonary-artery–occlusion pressure 4 – 6 ; and the insertion of a PAC often changes therapy. 6 – 8 Although many critically ill patients receive PACs, 9 no clear clinical benefit has been associated with their use. 10 – 12 Practitioners often misinterpret the information obtained by means of a PAC or act . . .

To determine the levels of glutathione and cysteine in patients with ARDS and examine the effect of treatment with N-acetylcysteine (NAC) and L-2-oxothiazolidine-4-carboxylate (Procysteine; Clintec Technologies Inc; Chicago [OTZ]) on these levels and on common physiologic abnormalities, and organ dysfunction associated with ARDS. Randomized, double-blind, placebo-controlled, prospective clinical trial. ICUs in five clinical centers in the United States and Canada. Patients meeting a predetermined definition of ARDS and requiring mechanical ventilation. Standard care for ARDS and IV infusion, every 8 h for 10 days, of one of the following: NAC (70 mg/kg, n=14), OTZ (63 mg/kg, n=17), or placebo (n= 15). Roth antioxidants effectively repleted RBC glutathione gradually over the 10-day treatment period (47% and 49% increases from baseline values for NAC and OTZ, respectively). There was no difference in mortality among groups (placebo, 40%; NAC, 36%; OTZ, 35%). However, the number of days of acute lung injury was decreased and there was also a significant increase in cardiac index in both treatment groups (NAC/OTZ [+]14%; placebo [—]6%). Conclusions: Our findings suggest that repletion of glutathione may safely be accomplished with NAC or OTZ in patients with acute lung injury/ARDS. Such treatment may shorten the duration of acute lung injury, but larger studies are needed to confirm this.

Sepsis is an infection-induced syndrome defined as the presence of two or more of the following features of systemic inflammation: fever or hypothermia, leukocytosis or leukopenia, tachycardia, and tachypnea or a supranormal minute ventilation. 1 When an organ system begins to fail because of sepsis, the sepsis is considered severe. Each year, sepsis develops in more than 500,000 patients in the United States, and only 55 to 65 percent survive. 2 , 3 Fortunately, the death rates in some subgroups of patients with sepsis-induced organ failure have decreased, even though there is no specific therapy for sepsis. 3 , 4 The reduced mortality may be . . .