Iloprost in Acute Respiratory Distress Syndrome

NCT ID: NCT03111212

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-25

Study Completion Date

2021-08-14

Brief Summary

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The patients will be randomized into one of two groups. Both groups will receive standard care as is state of the art. The intervention group will receive Iloprost nebulized as inhalative therapy.

Detailed Description

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Conditions

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Respiratory Distress Syndrome, Adult

Keywords

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Acute respiratory distress syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iloprost

Group Type ACTIVE_COMPARATOR

Iloprost

Intervention Type DRUG

Iloprost nebulized

control

Group Type PLACEBO_COMPARATOR

control

Intervention Type DRUG

sodium chloride 0,9% nebulized

Interventions

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Iloprost

Iloprost nebulized

Intervention Type DRUG

control

sodium chloride 0,9% nebulized

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Horowitz index \<300
* Bilateral opacities on frontal chest radiograph
* requirement of positive pressure ventilation
* no clinical evidence of left atrial hypertension
* enrollment within 48h of onset of ARDS
* mechanical ventilation \<7 days

Exclusion Criteria

* age \<18 years
* mechanical ventilation \>7 days
* patient, surrogate or physician not committed to full intensive care support
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Rosenberger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Hospital Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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Haeberle HA, Calov S, Martus P, Serna-Higuita LM, Koeppen M, Goll A, Bernard A, Zarbock A, Meersch M, Weiss R, Mehrlander M, Marx G, Putensen C, Bakchoul T, Magunia H, Nieswandt B, Mirakaj V, Rosenberger P. Inhaled prostacyclin therapy in the acute respiratory distress syndrome: a randomized controlled multicenter trial. Respir Res. 2023 Feb 18;24(1):58. doi: 10.1186/s12931-023-02346-0.

Reference Type DERIVED
PMID: 36805707 (View on PubMed)

Haeberle H, Prohaska S, Martus P, Straub A, Zarbock A, Marx G, Zago M, Giera M, Koeppen M, Rosenberger P. Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study. Trials. 2020 Mar 4;21(1):242. doi: 10.1186/s13063-020-4163-0.

Reference Type DERIVED
PMID: 32131881 (View on PubMed)

Other Identifiers

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ThIlo

Identifier Type: -

Identifier Source: org_study_id