Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial.

INTRODUCTION: Constipation is a common problem in intensive care units. We assessed the efficacy and safety of laxative therapy aiming to promote daily defecation in reducing organ dysfunction in mechanically ventilated patients. METHODS: We conducted a prospective, randomized, controlled, nonblinded phase II clinical trial at two general intensive care units. Patients expected to remain ventilated for over 3 days were randomly assigned to daily defecation or control groups. The intervention group received lactulose and enemas to produce 1-2 defecations per day. In the control group, absence of defecation was tolerated up to 5 days. Primary outcome was the change in Sequential Organ Failure Assessment (SOFA) score between the date of enrollment and intensive care unit discharge, death or day 14. RESULTS: We included 88 patients. Patients in the treatment group had a higher number of defecations per day (1.3 ± 0.42 versus 0.7 ± 0.56, p < 0.0001) and lower percentage of days without defecation (33.1 ± 15.7% versus 62.3 ± 24.5%, p < 0.0001). Patients in the intervention group had a greater reduction in SOFA score (-4.0 (-6.0 to 0) versus -1.0 (-4.0 to 1.0), p = 0.036) with no difference in mortality rates or in survival time. Adverse events were more frequent in the treatment group (4.5 (3.0-8.0) versus 3.0 (1.0-5.7), p = 0.016), including more days with diarrhea (2.0 (1.0-4.0) versus 1.0 (0-2.0) days, p < 0.0001). Serious adverse events were rare and did not significantly differ between groups. CONCLUSIONS: Laxative therapy improved daily defecation in ventilated patients and was associated with a greater reduction in SOFA score. TRIAL REGISTRATION: Clinical Trials.gov NCT01607060, registered 24 May 2012.

Is venous blood drawn from femoral access adequate to estimate the central venous oxygen saturation and arterial lactate levels in critically ill patients?

OBJECTIVES: The purpose of this study was to test if venous blood drawn from femoral access can be used to estimate the central venous oxygen saturation and arterial lactate levels in critically ill patients. METHODS: Bland-Altman analysis and Spearman correlations were used to compare the femoral venous oxygen saturation and central venous oxygen saturation as well as arterial lactate levels and femoral lactate. A pre-specified subgroup analysis was conducted in patients with signs of hypoperfusion. In addition, the clinical agreement was also investigated. RESULTS: Blood samples were obtained in 26 patients. In 107 paired samples, there was a moderate correlation (r = 0.686, p < 0.0001) between the central venous oxygen saturation and femoral venous oxygen saturation with a bias of 8.24 ± 10.44 (95% limits of agreement: -12.23 to 28.70). In 102 paired samples, there was a strong correlation between the arterial lactate levels and femoral lactate levels (r = 0.972, p < 0.001) with a bias of -2.71 ± 9.86 (95% limits of agreement: -22.03 to 16.61). The presence of hypoperfusion did not significantly change these results. The clinical agreement for venous saturation was inadequate, with different therapeutic decisions in 22.4% of the situation; for lactate, this was the case only in 5.2% of the situations. CONCLUSION: Femoral venous oxygen saturation should not be used as a surrogate of central venous oxygen saturation. However, femoral lactate levels can be used in clinical practice, albeit with caution.