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Influence of in-line microfilters on systemic inflammation in adult critically ill patients: a prospective, randomized, controlled open-label trial.

Gradwohl-Matis I, Brunauer A, Dankl D, Wirthel E, Meburger I, Bayer A, Mandl M, Dünser MW, Grander W - Ann Intensive Care (2015)

Bottom Line: The study groups did not differ in any baseline variable.Results did not change when only patients with an intensive care unit length of stay of greater than 7 days were included in the analysis.Use of in-line microfilters was associated with additional costs.

View Article: PubMed Central - PubMed

Affiliation: Interdisciplinary Intensive Care Units, Department of Anesthesiology, Perioperative and General Intensive Care, Salzburg University Hospital and Paracelsus Private Medical University, Müllner Hauptstrasse 48, 5020, Salzburg, Austria. I.Gradwohl-Matis@salk.at.

ABSTRACT

Background: In critically ill children, in-line microfilters may reduce the incidence of the systemic inflammatory response syndrome (SIRS), the overall complication and organ dysfunction rate. No data on the use of in-line microfilters exist in critically ill adults.

Methods: In this prospective, randomized, controlled open-label study, we evaluated the influence of in-line microfilters on systemic immune activation in 504 critically ill adults with a central venous catheter in place and an expected length of stay in the intensive care unit >24 h. Patients were randomized to have in-line microfilters placed into all intravenous lines (intervention group) or usual care (control group). The primary endpoint was the number of intensive care unit days with SIRS. Secondary endpoints were the incidence of SIRS, SIRS criteria per day, duration of invasive mechanical ventilation, intensive care unit length of stay, the incidence of acute lung injury, maximum C-reactive protein, maximum white blood cell count, incidence of new candida and/or central-line-associated bloodstream infections, incidence of new thromboembolic complications, cumulative insulin requirements and presence of hyper- or hypoglycemia.

Results: The study groups did not differ in any baseline variable. There was no difference in the number of days in the intensive care unit with SIRS between microfilter and control patients [2 (0.8-4.7) vs. 1.8 (0.7-4.4), p = 0.62]. Except for a higher incidence of SIRS in microfilter patients (99.6 vs. 96.8 %, p = 0.04), no difference between the groups was observed in any secondary outcome parameter. Results did not change when only patients with an intensive care unit length of stay of greater than 7 days were included in the analysis. The rate of adverse events was comparable between microfilter and control patients. In two patients allocated to the microfilter group, the study intervention was discontinued for technical reasons. Use of in-line microfilters was associated with additional costs.

Conclusions: The use of in-line microfilters failed to modulate systemic inflammation and clinical outcome parameters in critically ill adults.

Trial registration: Clinical Trials NCT01534390.

No MeSH data available.


Related in: MedlinePlus

Overview of patient enrollment. ICU intensive care unit, LOS length of stay
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Fig2: Overview of patient enrollment. ICU intensive care unit, LOS length of stay

Mentions: Of 1716 patients screened for study eligibility, 504 patients were enrolled in the trial. No patient was lost to follow-up (Fig. 2). The study groups did not differ in demographic data, comorbidities, admission diagnoses or other clinical data (Table 1). There was no difference in the number of days in the ICU with SIRS between microfilter and control patients. Except for a higher incidence of SIRS in in-line microfilter patients, no difference between groups was observed in any secondary outcome parameter. The results did not change when only patients with an ICU length of stay of greater than 7 days were included in the analysis (Table 2). The maximum white blood cell count and maximum C-reactive protein serum concentrations did not differ between the groups (Fig. 3). The rate of adverse events was comparable between microfilter and control patients (Table 3). In two patients allocated to the in-line microfilter group, the study intervention was discontinued. In one patient, a leakage of propofol occurred from the in-line microfilter leading to inadequate sedation and patient-ventilator dyssynchrony. In the other patient, the three-way cock proximal of the in-line microfilter was missing and rescue fluids could only be administered at a too low velocity. The use of in-line microfilters in the study group resulted in additional median costs per patient of 54.7 (54.7–109.4) € and 25 544.9 € for the entire study group.Fig. 2


Influence of in-line microfilters on systemic inflammation in adult critically ill patients: a prospective, randomized, controlled open-label trial.

Gradwohl-Matis I, Brunauer A, Dankl D, Wirthel E, Meburger I, Bayer A, Mandl M, Dünser MW, Grander W - Ann Intensive Care (2015)

Overview of patient enrollment. ICU intensive care unit, LOS length of stay
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4633471&req=5

Fig2: Overview of patient enrollment. ICU intensive care unit, LOS length of stay
Mentions: Of 1716 patients screened for study eligibility, 504 patients were enrolled in the trial. No patient was lost to follow-up (Fig. 2). The study groups did not differ in demographic data, comorbidities, admission diagnoses or other clinical data (Table 1). There was no difference in the number of days in the ICU with SIRS between microfilter and control patients. Except for a higher incidence of SIRS in in-line microfilter patients, no difference between groups was observed in any secondary outcome parameter. The results did not change when only patients with an ICU length of stay of greater than 7 days were included in the analysis (Table 2). The maximum white blood cell count and maximum C-reactive protein serum concentrations did not differ between the groups (Fig. 3). The rate of adverse events was comparable between microfilter and control patients (Table 3). In two patients allocated to the in-line microfilter group, the study intervention was discontinued. In one patient, a leakage of propofol occurred from the in-line microfilter leading to inadequate sedation and patient-ventilator dyssynchrony. In the other patient, the three-way cock proximal of the in-line microfilter was missing and rescue fluids could only be administered at a too low velocity. The use of in-line microfilters in the study group resulted in additional median costs per patient of 54.7 (54.7–109.4) € and 25 544.9 € for the entire study group.Fig. 2

Bottom Line: The study groups did not differ in any baseline variable.Results did not change when only patients with an intensive care unit length of stay of greater than 7 days were included in the analysis.Use of in-line microfilters was associated with additional costs.

View Article: PubMed Central - PubMed

Affiliation: Interdisciplinary Intensive Care Units, Department of Anesthesiology, Perioperative and General Intensive Care, Salzburg University Hospital and Paracelsus Private Medical University, Müllner Hauptstrasse 48, 5020, Salzburg, Austria. I.Gradwohl-Matis@salk.at.

ABSTRACT

Background: In critically ill children, in-line microfilters may reduce the incidence of the systemic inflammatory response syndrome (SIRS), the overall complication and organ dysfunction rate. No data on the use of in-line microfilters exist in critically ill adults.

Methods: In this prospective, randomized, controlled open-label study, we evaluated the influence of in-line microfilters on systemic immune activation in 504 critically ill adults with a central venous catheter in place and an expected length of stay in the intensive care unit >24 h. Patients were randomized to have in-line microfilters placed into all intravenous lines (intervention group) or usual care (control group). The primary endpoint was the number of intensive care unit days with SIRS. Secondary endpoints were the incidence of SIRS, SIRS criteria per day, duration of invasive mechanical ventilation, intensive care unit length of stay, the incidence of acute lung injury, maximum C-reactive protein, maximum white blood cell count, incidence of new candida and/or central-line-associated bloodstream infections, incidence of new thromboembolic complications, cumulative insulin requirements and presence of hyper- or hypoglycemia.

Results: The study groups did not differ in any baseline variable. There was no difference in the number of days in the intensive care unit with SIRS between microfilter and control patients [2 (0.8-4.7) vs. 1.8 (0.7-4.4), p = 0.62]. Except for a higher incidence of SIRS in microfilter patients (99.6 vs. 96.8 %, p = 0.04), no difference between the groups was observed in any secondary outcome parameter. Results did not change when only patients with an intensive care unit length of stay of greater than 7 days were included in the analysis. The rate of adverse events was comparable between microfilter and control patients. In two patients allocated to the microfilter group, the study intervention was discontinued for technical reasons. Use of in-line microfilters was associated with additional costs.

Conclusions: The use of in-line microfilters failed to modulate systemic inflammation and clinical outcome parameters in critically ill adults.

Trial registration: Clinical Trials NCT01534390.

No MeSH data available.


Related in: MedlinePlus