Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial

Livingston, Michael H.; Mahant, Sanjay; Ratjen, Félix; Connolly, Bairbre; Thorpe, Kevin E.; Mamdani, Muhammad; MacLusky, Ian; Laberge, Sophie; Giglia, Lucy; Walton, J. Mark; Yang, Connie L.; Roberts, Ashley; Shawyer, Anna C.; Brindle, Mary; Parsons, Simon; Stoian, Cristina; Cohen, Eyal

doi:10.1186/s13063-017-2026-0

Cited by 15 publications

(11 citation statements)

References 42 publications

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“…Beyond this window of opportunity, there is no evidence confirming its efficacy. Conventionally, three doses are administered over three consecutive days , but there has been no definite basis for this regimen and there are no studies that have compared different numbers of doses in children.…”

Section: Introductionmentioning

confidence: 99%

Intrapleural streptokinase is effective and safe for children with multi‐loculated empyema regardless of the time from disease onset

et al. 2018

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Section: Introductionmentioning

confidence: 99%

Intrapleural streptokinase is effective and safe for children with multi‐loculated empyema regardless of the time from disease onset

et al. 2018

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“…32 Although participating hospitals received suggestions for standard care, we made no attempt to ensure that suggestions for chest tube size, length or type of antibiotic treatment, or other aspects of routine care were implemented. 23 This explanation for our null observation, while possible, is unlikely given the similarities in the 2 groups at baseline, rigorous blinding and randomization procedures, and the lack of effect on the primary outcome when adjusted for study site and other confounders. Third, some participants withdrew from the study before completing all 3 study treatments.…”

Section: Limitationsmentioning

confidence: 85%

“…The DTPA trial was a multicenter, parallel-group, placebocontrolled, superiority randomized clinical trial involving 6 Canadian children's hospitals (Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec; Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario; The Hospital for Sick Children, University of Toronto, Toronto, Ontario; McMaster Children's Hospital, McMaster University, Hamilton, Ontario; Alberta Children's Hospital, University of Calgary, Calgary, Alberta; and British Columbia's Children's Hospital, University of British Columbia, Vancouver, British Columbia). The study protocol was registered at ClinicalTrials.gov (NCT01717742) and published in full previously 23 and is available in Supplement 1. Ethics approval was obtained from the institutional review board at the Hospital for Sick Children and at each participating hospital.…”

Section: Methodsmentioning

confidence: 99%

Effectiveness of Intrapleural Tissue Plasminogen Activator and Dornase Alfa vs Tissue Plasminogen Activator Alone in Children with Pleural Empyema

et al. 2020

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IMPORTANCE Clinical guidelines recommend that children with pleural empyema be treated with chest tube insertion and intrapleural fibrinolytics. The addition of dornase alfa (DNase) has been reported to improve outcomes in adults but remains unproven in children. OBJECTIVE To determine if intrapleural tissue plasminogen activator (tPA) and DNase is more effective than tPA and placebo at reducing hospital length of stay in children with pleural empyema. DESIGN, SETTING, AND PARTICIPANTS This multicenter, parallel-group, placebo-controlled, superiority randomized clinical trial included children diagnosed as having pleural empyema requiring drainage aged 6 months to 18 years treated at 6 tertiary Canadian children's hospitals. A total of 379 children were assessed for eligibility; 281 were excluded and 98 were randomized. One child was excluded after randomization for not meeting the inclusion criteria. Data were collected from March 4, 2013, to December 13, 2017. INTERVENTIONS Participants underwent chest tube insertion and 3 daily administrations of intrapleural tPA, 4 mg, followed by DNase, 5 mg (intervention group), or 5 mL of normal saline (placebo; control group). Participants, families, clinical staff, and members of the study team were blinded to allocation. MAIN OUTCOMES AND MEASURES The primary outcome was hospital length of stay from chest tube insertion to discharge. Secondary outcomes included time to meeting discharge criteria, time to chest tube removal, mean fever duration, additional pleural drainage procedures, hospital readmissions, and total health care cost. RESULTS Of the 97 analyzed children with pleural empyema, 52 (54%) were male, and the mean (SD) age was 5.1 (3.6) years. A total of 49 children were randomized to tPA and DNase and 48 were randomized to tPA and placebo. Treatment with tPA and DNase was not associated with decreased hospital length of stay compared with tPA and placebo (mean [SD] length of stay, 9.0 [4.9] vs 9.1 [5.3] days; mean difference, −0.1 days; 95% CI, −2.0 to 2.1; P = .96). Similarly, no significant differences were observed for any of the secondary outcomes. Of the 14 adverse events in the tPA and DNase group, 6 (43%) were serious; of the 21 adverse events in the tPA and placebo group, 8 (38%) were serious. There were no deaths. CONCLUSIONS AND RELEVANCE The addition of DNase to intrapleural tPA for children with pleural empyema had no effect on hospital length of stay or other outcomes compared with tPA with placebo. Clinical practice guidelines should continue to support the use of chest tube insertion and intrapleural fibrinolytics alone as first-line treatment for pediatric empyema. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01717742

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“…These statistics will be compiled in the absence of the patient. The length of hospital stay will be measured in days [ 44 ].…”

Section: Methodsmentioning

confidence: 99%

Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial

Shen

Guo

et al. 2021

Trials

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Background Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease characterized by coughing, the production of excess sputum, and dyspnea. Patients with excessively thick sputum may have frequent attacks or develop more serious disease. The guidelines recommend airway clearance for patients with excessive sputum who are hospitalized with COPD. The active cycle of breathing technique is the most common non-pharmacological airway clearance technique used by physiotherapists. However, the effectiveness of the technique is not always guaranteed. Active cycle of breathing techniques require the initial dilution of the sputum, usually by inhalation drugs, which may have limited effects. Recent studies have found that phonophoresis decreases inflammation, suggesting the potential of the combined usage of active cycle of breathing techniques and phonophoresis. Therefore, the aim of this study is to explore the effectiveness and safety of combining active cycle of breathing technique and phonophoresis in treating COPD patients. Methods and analysis We propose a single-blind randomized controlled trial using 75 hospitalized patients diagnosed with COPD with excessive sputum production. The patients will be divided into three groups. The intervention group will receive active cycle of breathing techniques combined with phonophoresis. The two comparison groups will be treated with active cycle of breathing techniques and phonophoresis, respectively. The program will be implemented daily for 1 week. The primary outcomes will be changes in sputum viscosity and production, lung function, and pulse oximetry. Secondary outcomes include the assessment of COPD and anxiety, measured by the COPD Assessment Test scale and the Anxiety Inventory for Respiratory Disease, respectively; self-satisfaction; the degree of cooperation; and the length of hospital stay. All outcome measures, with the exception of sputum production and additional secondary outcomes, will be assessed at the commencement of the study and after 1 week’s intervention. Analysis of variance will be used to investigate differences between the groups, and a p-value of less than 0.05 (two-tailed) will be considered statistically significant. Discussion This study introduces a combination of active cycle of breathing techniques and phonophoresis to explore the impact of these interventions on patients hospitalized with COPD. If this combined intervention is shown to be effective, it may prove to be a better treatment for patients with COPD. Trial registration The trial was registered prospectively on the Chinese Clinical Trial Registry on 24 December 2019.ClinicalTrials.gov ChiCTR1900028506. Registered on December 2019.

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Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial

Cited by 15 publications

References 42 publications

Intrapleural streptokinase is effective and safe for children with multi‐loculated empyema regardless of the time from disease onset

Intrapleural streptokinase is effective and safe for children with multi‐loculated empyema regardless of the time from disease onset

Effectiveness of Intrapleural Tissue Plasminogen Activator and Dornase Alfa vs Tissue Plasminogen Activator Alone in Children with Pleural Empyema

Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial

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