Evidence map›Paper›PMID 28646887›Full record

Trial reportTrials2017

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

Michael H Livingston, Sanjay Mahant, Felix Ratjen, Bairbre L Connolly, Kevin Thorpe, Muhammad Mamdani, Ian Maclusky, Sophie Laberge, Lucy Giglia, J Mark Walton and 7 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01717742 (Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01717742 phase3completednot on this map

Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)

TypeinterventionalSponsorThe Hospital for Sick ChildrenRan2012 to 2017Enrolled97ConditionsPleural EmpyemaArmsTPA (Tissue Plasminogen Activator), DNase, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 1 country.

Michael H LivingstonMcMaster Children's Hospital, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Sanjay MahantThe Hospital for Sick Children, Department of Pediatrics, University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.
Felix RatjenThe Hospital for Sick Children, Department of Pediatrics, University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.
Bairbre L ConnollyThe Hospital for Sick Children, Department of Pediatrics, University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.
Kevin ThorpeDalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, ON, M5T 3M7, Canada.
Muhammad MamdaniApplied Health Research Centre of the Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
Ian MacluskyChildren's Hospital of Eastern Ontario, University of Ottawa, 401 Smyth Road, Ottawa, ON, K1H 5B2, Canada.
Sophie LabergeCentre Hospitalier Universitaire Sainte-Justine, Université de Montréal, 3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.
Lucy GigliaMcMaster Children's Hospital, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
J Mark WaltonMcMaster Children's Hospital, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Connie L YangDepartment of Pediatrics, Division of Respiratory Medicine, British Columbia's Children's Hospital, University of British Columbia, 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada.
Ashley RobertsDepartment of Pediatrics, Division of Respiratory Medicine, British Columbia's Children's Hospital, University of British Columbia, 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada.
Anna C ShawyerAlberta Children's Hospital, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB, T3B 6A9, Canada.
Mary BrindleAlberta Children's Hospital, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB, T3B 6A9, Canada.
Simon J ParsonsAlberta Children's Hospital, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB, T3B 6A9, Canada.
Cristina A StoianAlberta Children's Hospital, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB, T3B 6A9, Canada.
Eyal CohenThe Hospital for Sick Children, Department of Pediatrics, University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada. eyal.cohen@sickkids.ca.
SickKids Foundation · CAUniversity of Calgary · CABC Children's Hospital · CAMcMaster University · CAUniversity of Toronto · CAAlberta Children's Hospital · CACentre Hospitalier Universitaire Sainte-Justine · CAHospital for Sick Children · CAMcMaster Children's Hospital · CAUniversity of Ottawa · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA randomized controlled trial of adults with empyema recently demonstrated decreased length of stay in hospital in patients treated with intrapleurally administered dornase alfa and fibrinolytics compared to fibrinolytics alone. Whether this treatment strategy is safe and effective in children remains unknown. METHODS/

designThis study protocol is for a superiority, placebo-controlled, parallel-design, multicenter randomized controlled trial. The participants are previously well children admitted to a children's hospital with a diagnosis of empyema requiring chest tube insertion and fibrinolytics administered intrapleurally. Children will be randomized after the treating physician has decided that pleural drainage is required but prior to chest tube insertion. After chest tube insertion, participants in the treatment group will receive intrapleurally administered tissue plasminogen activator (tPA) 4 mg followed by dornase alfa 5 mg. Participants in the placebo group will receive tPA 4 mg followed by normal saline. Study treatments will be administered once daily for 3 days. All participants, parents or caregivers, clinicians, and research personnel will remain blinded. The primary outcome is length of stay from chest tube insertion to discharge from hospital. Secondary outcomes include time to meeting discharge criteria, chest tube duration, fever duration, need for additional procedures, adverse events, hospital readmission, cost of hospitalization, and mortality. DISCUSSION: This multicenter randomized controlled trial will assess the safety, effectiveness, and cost-effectiveness of combined treatment with dornase alfa and fibrinolytics compared to fibrinolytics alone for the treatment of empyema in children.

trial registrationClinicalTrials.gov: NCT01717742 . Registered on 8 October 2012.

Indexed as

AdolescentAge FactorsCanadaChest TubesChildChild, PreschoolClinical ProtocolsCost-Benefit AnalysisDeoxyribonuclease IDrainageDrug Administration RoutesDrug CostsDrug Therapy, CombinationEmpyema, PleuralFemaleFibrinolytic AgentsDeoxyribonuclease Idornase alfaFibrinolytic AgentsRecombinant ProteinsTissue Plasminogen ActivatorChest tubesChildrenEmpyemaFibrinolytic agentsRandomized controlled trial

Identifiers

PMID28646887
PMCPMC5482972
OpenAlexW2646828059

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.