NCT03334227 (OPTISEPSIS) is a NA clinical trial of High-Flow nasal cannula (HFNC) in Severe Sepsis, sponsored by Althaia Xarxa Assistencial Universitària de Manresa.

Who is sponsoring NCT03334227?

NCT03334227 is sponsored by Althaia Xarxa Assistencial Universitària de Manresa.

What drugs are being tested in NCT03334227?

Interventions in NCT03334227: High-Flow nasal cannula (HFNC).

What condition does NCT03334227 study?

NCT03334227 studies Severe Sepsis.

Is NCT03334227 still recruiting?

NCT03334227 is currently terminated. Last updated 14 January 2021.

Last reviewed 2021-01-14 · How we verify

NCT03334227: OPTISEPSIS

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

High Flow Nasal Cannula in Severe Sepsis

Terminated NA Last updated 14 January 2021

What this trial tests

NA trial testing High-Flow nasal cannula (HFNC) in Severe Sepsis in 39 participants. Terminated before completion.

Timeline

8 January 2018

Primary endpoint
28 November 2020

28 December 2020

Quick facts

Lead sponsor	Althaia Xarxa Assistencial Universitària de Manresa
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	8 January 2018
Primary completion	28 November 2020
Estimated completion	28 December 2020
Sites	1 location across Spain

Drugs / interventions tested

High-Flow nasal cannula (HFNC)

Conditions studied

Severe Sepsis — all drugs for Severe Sepsis →

Sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Who can join

Adults 18 to 99, any sex, with Severe Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Severe sepsis leads a high morbidity and mortality by causing organ damage at distance. The treatment relies on early antibiotic therapy and hemodynamic resuscitation. Hypothesis: high flow nasal cannula (HFNC) could reduce work of breathing and improve the outcome of patients with severe sepsis and peripheral perfusion. Objective: the aim of this study is to evaluate the efficacy of HFNC for improving sixty-day survival in patients with severe sepsis. Design: multicenter parallel-group randomized clinical trial. Method: 592 adult patients with a diagnosis of severe sepsis in the first 12 hours of admission in the Emergency Room will be randomly assigned to an experimental or control group. In the experimental group, HFNC will be administered until the resolution of sepsis or until required mechanical ventilation, either invasive or non-invasive. In the Control group, conventional oxygen will be administered, if required. Sixty-day survival will be the primary outcome. The study is powered to demonstrate an improvement in survival from 70% in control group up to 80% in the HFNC group. The secondary outcomes will be reducing the need for vital support (mechanical ventilation, dialysis, vasoactive drugs) and physiological (acidosis, clearance of lactate, SvO2 and SOFA). Statistical analysis: Kaplan-Meier curves and Cox proportional hazard models will be calculated for all-cause sixty-day survival. If the results are conclusive, they will have immediate application in medical practice.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Severe Sepsis

Currently open trials in the same condition.

NCT06143137 — Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outco · recruiting
NCT04955210 — A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children · recruiting
NCT05413343 — Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients · active not recruiting

Other Althaia Xarxa Assistencial Universitària de Manresa trials

Trials by the same sponsor.

NCT07194824 — A Penicillin Allergy Delabeling Inhospital Model Hospitalized Patients · NA · terminated
NCT05904392 — Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections · NA · completed
NCT05877131 — Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercus · Phase 4 · unknown
NCT05526053 — Lung Volume Preservation During Extubation · NA · completed
NCT05663788 — Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer · NA · unknown

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 NCT03334227 (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 Althaia Xarxa Assistencial Universitària de Manresa
Last refreshed: 14 January 2021

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/NCT03334227.

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