About: The effect of prostacyclin (Iloprost) infusion at a dose of 1 ng/kg/min for 72 hours compared to placebo in mechanically ventilated patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial

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About: The effect of prostacyclin (Iloprost) infusion at a dose of 1 ng/kg/min for 72 hours compared to placebo in mechanically ventilated patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	The effect of prostacyclin (Iloprost) infusion at a dose of 1 ng/kg/min for 72 hours compared to placebo in mechanically ventilated patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial
Creator	Perner, Anders Bestle, Morten Kristiansen, Klaus Clausen, Niels Johansson, Pär Stensballe, Jakob Søe-Jensen, Peter
Source	Medline; PMC
abstract	OBJECTIVES: To investigate the effect of continuous infusion of the potential endothelial cytoprotective agent prostacyclin (Iloprost) 1 ng/kg/min vs. placebo for 72 hours on pulmonary endotheliopathy in mechanically ventilated COVID-19 patients. TRIAL DESIGN: A multicenter, randomized (1:1, active: placebo), blinded, parallel group exploratory trial PARTICIPANTS: Inclusion criteria are: Adult patients (>18 years); Confirmed COVID-19 infection; Need for mechanical interventions; Endothelial biomarker soluble thrombomodulin >4ng/ml. Exclusion criteria: Withdrawal from active therapy; Pregnancy (non-pregnancy confirmed by patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG); Known hypersensitivity to iloprost or to any of the other ingredients; Previously included in this trial or a prostacyclin trial within 30 days; Consent cannot be obtained; Life-threatening bleeding defined by the treating physician; Known severe heart failure (NYHA class IV); Suspected acute coronary syndrome The study is conducted at five intensive care units in the Capital Region of Denmark at Rigshospitalet, Herlev Hospital, Hvidovre Hospital, Bispebjerg Hospital, Nordsjællands Hospital. INTERVENTION AND COMPARATOR: The patients are randomized to 72-hours continuous infusion of either prostacyclin (Iloprost/Ilomedin) at a dose of 1 ng/kg/min or Placebo (normal saline). MAIN OUTCOMES: Primary endpoint: Days alive without mechanical ventilation in the intensive care units within 28 days RANDOMISATION: The randomisation sequence is performed in permuted blocks of variable sizes stratified for trial site using centralised, concealed allocation. The randomisation sequence is generated 1:1 (active/placebo) using the online randomisation software ‘Sealed Envelope’ (https://www.sealedenvelope.com/). Once generated the randomisation sequence is formatted and uploaded into Research Electronic Data Capture system (REDCap) to facilitate centralised, web-based allocation according to local written instruction. BLINDING (MASKING): The following are blinded: all clinicians, patients, investigators, and those assessing the outcomes including the statisticians. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Forty patients are planned to be randomized to each group, with a total sample size of 80 patients. TRIAL STATUS: Protocol version 1.4 dated May 25, 2020. Recruitment is ongoing. The recruitment was started June 15, 2020 and the anticipated finish of recruitment is February 28, 2021 with 90 days follow up hereafter. TRIAL REGISTRATION: Trial registration at clinicaltrialregisters.eu; EudraCT no. 2020-001296-33 on 3 April 2020 and at ClinicalTrials.gov Identifier: NCT04420741 on 9 June 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
has issue date	2020-08-26(xsd:dateTime)
bibo:doi	10.1186/s13063-020-04696-2
bibo:pmid	32847626
has license	cc-by
sha1sum (hex)	a00206064aae18b8709a12604cf56582bc74b69d
schema:url	https://doi.org/10.1186/s13063-020-04696-2
resource representing a document's title	The effect of prostacyclin (Iloprost) infusion at a dose of 1 ng/kg/min for 72 hours compared to placebo in mechanically ventilated patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial
has PubMed Central identifier	PMC7447606
has PubMed identifier	32847626
schema:publication	Trials
resource representing a document's body	covid:a00206064aae18b8709a12604cf56582bc74b69d#body_text
is schema:about of	named entity 'investigator' named entity 'secondary endpoints' named entity 'endothelial' named entity 'investigational drug' named entity 'confidence intervals' named entity 'septic shock' named entity 'iloprost' named entity 'SUSAR' named entity 'Iloprost' named entity 'cardiac arrest' named entity 'ITT' named entity 'medical product' named entity 'citrate' named entity 'mechanical ventilation' named entity 'P-values' named entity 'iloprost' named entity 'Iloprost' named entity 'intensive care' named entity 'Vancouver' named entity 'endothelium' named entity 'experimental group' named entity 'life-threatening' named entity 'follow-up' named entity 'Clinical immunology' named entity 'informed consent' named entity 'respiratory failure' named entity 'adverse reaction' named entity 'placebo' named entity 'endothelial' named entity 'organ failure' named entity 'consent form' named entity 'Danish Medicines Agency' named entity 'Pulmonary embolism' named entity 'research purposes' named entity 'endothelial' named entity 'biomarkers' named entity 'Ethics' named entity 'mechanical ventilation' named entity 'infusion' named entity 'isotonic saline' named entity 'saline' named entity 'plasma' named entity 'ICU' named entity 'investigational drug' named entity 'STEMI' named entity 'placebo' named entity 'platelet count' named entity 'SOFA score' named entity 'metastatic cancer' named entity 'Haemostasis' named entity 'cut-off' named entity 'endothelium' named entity 'ICU' named entity 'bilirubin' named entity 'placebo controlled' named entity 'CRF' named entity 'endothelial dysfunction' named entity 'Hubei' named entity 'ICU' named entity 'PGI' named entity 'ventilator' named entity 'ischemia-reperfusion injury' named entity 'confounders' named entity 'infusion' named entity 'investigational drug' named entity 'Pregnancy' named entity 'iloprost' named entity 'Hellerup' named entity 'circulatory failure' named entity 'rescue therapy' named entity 'hematology' named entity 'ICU' named entity 'adverse reactions' named entity 'infusion' named entity 'chronic cardiovascular disease'

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