NCT03788837 (I-MICRO) is a Phase 3 clinical trial of ILOPROST in Septic Shock Hyperdynamic, sponsored by Assistance Publique - Hôpitaux de Paris.

Who is sponsoring NCT03788837?

NCT03788837 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT03788837?

Interventions in NCT03788837: ILOPROST, NaCl.

What condition does NCT03788837 study?

NCT03788837 studies Septic Shock Hyperdynamic.

Is NCT03788837 still recruiting?

NCT03788837 is currently completed. Last updated 3 July 2024.

Last reviewed 2024-07-03 · How we verify

NCT03788837: I-MICRO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ILOPROST in Septic Shock With Persistent Microperfusion Defects (I-MICRO)

Completed Phase 3 Last updated 3 July 2024

What this trial tests

Phase 3 trial testing ILOPROST in Septic Shock Hyperdynamic in 240 participants. Completed in 18 January 2024.

Timeline

3 July 2019

Primary endpoint
5 January 2024

18 January 2024

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	240
Start date	3 July 2019
Primary completion	5 January 2024
Estimated completion	18 January 2024
Sites	1 location across France

Drugs / interventions tested

ILOPROST — full drug profile →
NaCl — full drug profile →

Conditions studied

Septic Shock Hyperdynamic — all drugs for Septic Shock Hyperdynamic →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 99, any sex, with Septic Shock Hyperdynamic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Septic shock remains a major cause of death in critically ill patients. Alterations in microcirculation have long been proposed as a key pathophysiological factor of organ dysfunction and death in septic shock patients. Persistence of mottling, prolonged skin recoloration time and cyanosis of the extremities are the easily and frequently observed manifestations of these microcirculatory disorders. Ilomedin is a prostaglandin analog with a potent vasodilatory effect together with anti-thrombotic properties (inhibition of platelet aggregation) preferentially at the microcirculatory level. An increase in cardiac output with increased arterial oxygen delivery has been observed in clinical and preclinical studies with no episodes of hypotension. Improvement in mesenteric perfusion has moreover been observed in experimental sepsis using Ilomedin. Our group has furthermore reported that administration of Ilomedin in patients with refractory septic shock (peripheral hypoperfusion) resulted in a rapid and sustained improvement in peripheral perfusion. Altogether, Ilomedin may prevent or improve recovery of organ dysfunction in septic shock patients through recruitment of the microcirculation and, thereby, ultimately improve outcome.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Assistance Publique - Hôpitaux de Paris trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03788837 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
Last refreshed: 3 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03788837.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing