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  1. Article ; Online: Surfactant replacement therapy in ARDS.

    Spragg, Roger G / Taut, Friedemann J H / Günther, Andreas / Rippin, Gerd

    Chest

    2009  Volume 136, Issue 1, Page(s) 321–322

    MeSH term(s) Drug Administration Schedule ; Humans ; Pulmonary Surfactants/administration & dosage ; Recombinant Proteins/administration & dosage ; Respiratory Distress Syndrome, Adult/drug therapy
    Chemical Substances Pulmonary Surfactants ; Recombinant Proteins ; Venticute
    Language English
    Publishing date 2009-07
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 1032552-9
    ISSN 1931-3543 ; 0012-3692
    ISSN (online) 1931-3543
    ISSN 0012-3692
    DOI 10.1378/chest.09-0787
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Ui III Zs.45: Show issues Location:
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  2. Article ; Online: An informatics strategy to assure enrollment criteria compliance in studies of the critically ill.

    Spragg, Roger G / Masys, Daniel R / Sergeant, David / Lawrie, Thomas / Taut, Friedemann J H

    Contemporary clinical trials

    2010  Volume 31, Issue 6, Page(s) 530–535

    Abstract: Up to 18% of acutely ill patients randomized into multicenter clinical trials may not satisfy inclusion/exclusion criteria. To improve compliance with such criteria in an ICU-based multicenter international drug trial, we established a novel Internet/ ... ...

    Abstract Up to 18% of acutely ill patients randomized into multicenter clinical trials may not satisfy inclusion/exclusion criteria. To improve compliance with such criteria in an ICU-based multicenter international drug trial, we established a novel Internet/telephone-based strategy for providing rapid case approval or disapproval by centralized panels of critical care physicians. We assessed whether these panels could acquire and record accurate patient information, and whether this approach would minimize enrollment of ineligible patients and could be accomplished in a timely fashion. Analysis of the first 1000 submitted patients showed accurate data capture for 98.7% of enrolled and randomized patients. Median response time from case submission to panel member decision was 34.7 min. Over 99% of enrolled patients met critical study criteria. We conclude that, an Internet-based communications strategy appears to be a valuable adjunct to multicenter clinical trials in acutely ill patients when rapid assurance of eligibility is required.
    MeSH term(s) Critical Illness ; Data Collection ; Humans ; Intensive Care Units ; Internet ; Medical Informatics Applications ; Multicenter Studies as Topic ; Patient Selection ; Randomized Controlled Trials as Topic/methods ; Telephone
    Language English
    Publishing date 2010-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2182176-8
    ISSN 1559-2030 ; 1551-7144
    ISSN (online) 1559-2030
    ISSN 1551-7144
    DOI 10.1016/j.cct.2010.07.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Recombinant surfactant protein C-based surfactant for patients with severe direct lung injury.

    Spragg, Roger G / Taut, Friedemann J H / Lewis, James F / Schenk, Peter / Ruppert, Clemens / Dean, Nathan / Krell, Kenneth / Karabinis, Andreas / Günther, Andreas

    American journal of respiratory and critical care medicine

    2011  Volume 183, Issue 8, Page(s) 1055–1061

    Abstract: Rationale: Patients with acute lung injury have impaired function of the lung surfactant system. Prior clinical trials have shown that treatment with exogenous recombinant surfactant protein C (rSP-C)-based surfactant results in improvement in blood ... ...

    Abstract Rationale: Patients with acute lung injury have impaired function of the lung surfactant system. Prior clinical trials have shown that treatment with exogenous recombinant surfactant protein C (rSP-C)-based surfactant results in improvement in blood oxygenation and have suggested that treatment of patients with severe direct lung injury may decrease mortality.
    Objectives: Determine the clinical benefit of administering an rSP-C-based synthetic surfactant to patients with severe direct lung injury due to pneumonia or aspiration.
    Methods: A prospective randomized blinded study was performed at 161 centers in 22 countries. Patients were randomly allocated to receive usual care plus up to eight doses of rSP-C surfactant administered over 96 hours (n = 419) or only usual care (n = 424).
    Measurements and main results: Mortality to 28 days after treatment, the requirement for mechanical ventilation, and the number of nonpulmonary organ failure-free days were not different between study groups. In contrast to prior studies, there was no improvement in oxygenation in patients receiving surfactant compared with the usual care group. Investigation of the possible reasons underlying the lack of efficacy suggested a partial inactivation of rSP-C surfactant caused by a step of the resuspension process that was introduced with this study.
    Conclusions: In this study, rSP-C-based surfactant was of no clinical benefit to patients with severe direct lung injury. The unexpected lack of improvement in oxygenation, coupled with the results of in vitro tests, suggest that the administered suspension may have had insufficient surface activity to achieve clinical benefit.
    MeSH term(s) Acute Lung Injury/drug therapy ; Acute Lung Injury/mortality ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Pulmonary Gas Exchange/drug effects ; Pulmonary Surfactant-Associated Protein C/administration & dosage ; Pulmonary Surfactant-Associated Protein C/therapeutic use ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/therapeutic use ; Respiration, Artificial ; Time Factors ; Treatment Outcome ; Young Adult
    Chemical Substances Pulmonary Surfactant-Associated Protein C ; Recombinant Proteins
    Language English
    Publishing date 2011-04-15
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1180953-x
    ISSN 1535-4970 ; 0003-0805 ; 1073-449X
    ISSN (online) 1535-4970
    ISSN 0003-0805 ; 1073-449X
    DOI 10.1164/rccm.201009-1424OC
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: A Search for subgroups of patients with ARDS who may benefit from surfactant replacement therapy: a pooled analysis of five studies with recombinant surfactant protein-C surfactant (Venticute).

    Taut, Friedemann J H / Rippin, Gerd / Schenk, Peter / Findlay, George / Wurst, Wilhelm / Häfner, Dietrich / Lewis, James F / Seeger, Werner / Günther, Andreas / Spragg, Roger G

    Chest

    2008  Volume 134, Issue 4, Page(s) 724–732

    Abstract: Background: Studies to date have shown no survival benefit for the use of exogenous surfactant to treat patients with the ARDS. To identify specific patient subgroups for future study, we performed an exploratory post hoc analysis of clinical trials of ... ...

    Abstract Background: Studies to date have shown no survival benefit for the use of exogenous surfactant to treat patients with the ARDS. To identify specific patient subgroups for future study, we performed an exploratory post hoc analysis of clinical trials of recombinant surfactant protein-C (rSP-C) surfactant (Venticute; Nycomed GmbH; Konstanz, Germany).
    Methods: We performed a pooled analysis of all five multicenter studies in which patients with ARDS due to various predisposing events were treated with rSP-C surfactant. Patients received either usual care (n = 266) or usual care plus up to four intratracheal doses (50 mg/kg) of rSP-C surfactant (n = 266). Factors influencing the study end points were analyzed using descriptive statistics, analysis of covariance, and logistic regression models.
    Results: ARDS was most often associated with pneumonia or aspiration, sepsis, and trauma or surgery. For the overall patient population, treatment with rSP-C surfactant significantly improved oxygenation (p = 0.002) but had no effect on mortality (32.6%). Multivariate analysis showed age and acute physiology and chronic health evaluation (APACHE) II score to be the strongest predictors of mortality. In the subgroup of patients with severe ARDS due to pneumonia or aspiration, surfactant treatment was associated with markedly improved oxygenation (p = 0.0008) and improved survival (p = 0.018).
    Conclusions: rSP-C surfactant improved oxygenation in patients with ARDS irrespective of the predisposition. Post hoc evidence of reduced mortality associated with surfactant treatment was obtained in patients with severe respiratory insufficiency due to pneumonia or aspiration. Those patients are the focus of a current randomized, blinded, clinical trial with rSP-C surfactant.
    MeSH term(s) Adult ; Aged ; Female ; Humans ; Instillation, Drug ; Male ; Middle Aged ; Pulmonary Surfactants/administration & dosage ; Recombinant Proteins/administration & dosage ; Respiratory Distress Syndrome/drug therapy ; Trachea ; Treatment Outcome
    Chemical Substances Pulmonary Surfactants ; Recombinant Proteins ; Venticute
    Language English
    Publishing date 2008-08-08
    Publishing country United States
    Document type Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't
    ZDB-ID 1032552-9
    ISSN 1931-3543 ; 0012-3692
    ISSN (online) 1931-3543
    ISSN 0012-3692
    DOI 10.1378/chest.08-0362
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Effect of recombinant surfactant protein C-based surfactant on the acute respiratory distress syndrome.

    Spragg, Roger G / Lewis, James F / Walmrath, Hans-Dieter / Johannigman, Jay / Bellingan, Geoff / Laterre, Pierre-Francois / Witte, Michael C / Richards, Guy A / Rippin, Gerd / Rathgeb, Frank / Häfner, Dietrich / Taut, Friedemann J H / Seeger, Werner

    The New England journal of medicine

    2004  Volume 351, Issue 9, Page(s) 884–892

    Abstract: Background: Preclinical studies suggest that exogenous surfactant may be of value in the treatment of the acute respiratory distress syndrome (ARDS), and two phase 2 clinical trials have shown a trend toward benefit. We conducted two phase 3 studies of ... ...

    Abstract Background: Preclinical studies suggest that exogenous surfactant may be of value in the treatment of the acute respiratory distress syndrome (ARDS), and two phase 2 clinical trials have shown a trend toward benefit. We conducted two phase 3 studies of a protein-containing surfactant in adults with ARDS.
    Methods: In two multicenter, randomized, double-blind trials involving 448 patients with ARDS from various causes, we compared standard therapy alone with standard therapy plus up to four intratracheal doses of a recombinant surfactant protein C-based surfactant given within a period of 24 hours.
    Results: The overall survival rate was 66 percent 28 days after treatment, and the median number of ventilator-free days was 0 (68 percent range, 0 to 26); there was no significant difference between the groups in terms of mortality or the need for mechanical ventilation. Patients receiving surfactant had a significantly greater improvement in blood oxygenation during the initial 24 hours of treatment than patients receiving standard therapy, according to both univariate and multivariate analyses.
    Conclusions: The use of exogenous surfactant in a heterogeneous population of patients with ARDS did not improve survival. Patients who received surfactant had a greater improvement in gas exchange during the 24-hour treatment period than patients who received standard therapy alone, suggesting the potential benefit of a longer treatment course.
    MeSH term(s) APACHE ; Analysis of Variance ; Causality ; Double-Blind Method ; Female ; Humans ; Logistic Models ; Male ; Middle Aged ; Oxygen/blood ; Pulmonary Surfactant-Associated Protein C/adverse effects ; Pulmonary Surfactant-Associated Protein C/therapeutic use ; Pulmonary Surfactants/adverse effects ; Pulmonary Surfactants/therapeutic use ; Recombinant Proteins/adverse effects ; Recombinant Proteins/therapeutic use ; Respiration, Artificial ; Respiratory Distress Syndrome, Adult/drug therapy ; Respiratory Distress Syndrome, Adult/etiology ; Respiratory Distress Syndrome, Adult/mortality ; Respiratory Distress Syndrome, Adult/therapy ; Survival Rate ; Treatment Failure
    Chemical Substances Pulmonary Surfactant-Associated Protein C ; Pulmonary Surfactants ; Recombinant Proteins ; Oxygen (S88TT14065)
    Language English
    Publishing date 2004-08-26
    Publishing country United States
    Document type Clinical Trial ; Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa033181
    Database MEDical Literature Analysis and Retrieval System OnLINE

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