High Flow Nasal Cannula in Severe Sepsis

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2020-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of High-flow Nasal Cannula Oxygen Therapy in Sepsis Patients

NCT04560842

High Flow Nasal Cannula Sepsis Syndrome

UNKNOWN NA

CLinical Efficacy of Hemoperfusion With a Cytokine Adsorber in Norepinephrine-Resistant SEptic Shock

NCT05136183

Septic Shock Cytokine Storm

UNKNOWN NA

Citrulline in Severe Sepsis

NCT01474863

Severe Sepsis Acute Lung Injury

COMPLETED PHASE2

Neutrophil Elastase Inhibitor in Treatment of ARDS Patients With Mechanical Ventilation Caused by Sepsis

NCT05672472

Acute Respiratory Distress Syndrome

UNKNOWN NA

Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis

NCT04057872

Septic Shock

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Severe sepsis is a syndrome associated with severe infections with a high morbidity and mortality. In its most severe form, septic shock still leads to an in-hospital mortality of up to 50%. The pathophysiology of severe sepsis / septic shock includes increased work of breathing to compensate for tissue hypoperfusion-induced metabolic acidosis. This exaggerated work of breathing requires increased consumption of oxygen by respiratory muscles, which calls for a greater percentage of the already insufficient cardiac output, which can aggravate tissue hypoperfusion.

In the last decade, high flow nasal cannula (HFNC) appeared as an alternative ventilatory support intermediate between conventional oxygen and mechanical ventilation. Among others (3-7), the investigators have also demonstrated their effectiveness in patients with respiratory failure of different etiologies (8-11). Patients treated with HFNC quickly show a reduction of respiratory rate and respiratory work, associated with an improvement of the functional residual capacity and gas exchange. The absence of significant side effects and low cost makes HFNC especially attractive as adjunctive medical treatment in severe sepsis.

Then, the hypothesis is that in patients with severe sepsis, high flow nasal cannula (HFNC) therapy could reduce work of breathing, which would allow a redistribution of cardiac output from the respiratory muscles to other organs, improving peripheral perfusion with minor injury of organs at distance, less multiorgan failure and improved survival. Therefore, the aim of this study is to evaluate the efficacy of HFNC for improving sixty-day survival in patients with severe sepsis. This study will also provide a detailed evaluation of the HFNC's effects on the need for vital support (mechanical ventilation, dialysis, vasoactive drugs) and physiological parameters (acidosis, clearance of lactate, SvO2 and SOFA).

DESIGN Prospective, multicenter, randomized, controlled trial in 592 patients with severe sepsis admitted into a network of 18 ICUs from university and community hospitals in Spain to define the role of high flow oxygen therapy, with one experimental arm that will receive high flow oxygen therapy and a control arm that will receive conventional oxygen therapy if required.

Patients who consent will be randomized in a 1:1 ratio to receive HFNC or conventional treatment, which consists of adding oxygen on nasal prongs or Venturi mask only if hypoxemia is detected as SpO2 \< 92% by pulse oximetry.

STUDY ARMS

1. HFNC therapy (experimental group) Treatment with HFNC (Airvo2® Fisher \& Paykel, and AquaNASE® Armstrong Medical) will begin with high flow (50 L/min), high temperature and humidity and oxygen concentration adjusted for SpO2 \>92%, even with FiO2 of 0.21, if needed.

The rationale for this HFNC dosage is that minute ventilation can be already reduced with 30 L/min, but functional residual capacity and oxygenation maximally improve at higher flow. On the contrary, flow \>50 L/min is uncomfortable for many patients.

In the case of clinical intolerance, flow will be reduced to 40, 30 or 20 L/min. Yet it is not tolerated, HFNC will be stopped and patients will receive conventional oxygen if required, but will be evaluated as in the HFNC group by intention to treat.

In HFNC patients we propose an extra caution to avoid delaying a mechanical ventilation that would be beneficial. To do this, the ROX index (ROX = SpO2/FiO2/respiratory rate) will be calculated and if it is \< 5, it is recommended to assess mechanical ventilatory support, either invasive or non-invasive.
2. Conventional therapy (control group) Patients assigned to the conventional treatment will receive the standard care given at hospital which consists of adding oxygen on nasal prongs or Venturi mask only if hypoxemia is suggested by SpO2 \< 92% by pulse oximetry.

Target for oxygenation in both arms is SpO2 between 92% and 95%. SpO2 \>95% without oxygen supply is acceptable. On the contrary, SpO2 \<92% may be acceptable when needed for medical reasons, mainly chronic hypercapnic patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with severe sepsis will be randomized to recieve conventional oxygenotherapy if needed or high flow nasal cannula.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High-Flow nasal cannula (HFNC)

Treatment with HFNC will be adjusted for SpO2 \>92%, even with FiO2 of 0.21, if needed.

The rationale for this HFNC dosage is that minute ventilation can be already reduced with 30 L/min, but functional residual capacity and oxygenation maximally improve at higher flow. On the contrary, flow \>50 L/min is uncomfortable for many patients.

In the case of clinical intolerance, flow will be reduced to 40, 30 or 20 L/min. Yet it is not tolerated, HFNC will be stopped and patients will receive conventional oxygen if required, but will be evaluated as in the HFNC group by intention to treat.

Group Type EXPERIMENTAL

High-Flow nasal cannula (HFNC)

Intervention Type DEVICE

The patient will receive HFNC adjusted for SatO2 \> 92% and with, at least, 30 liters of total flow.

Conventional therapy

Patients assigned to the conventional treatment will receive the standard care given at hospital which consists of adding oxygen on nasal prongs or Venturi mask only if hypoxemia is suggested by SpO2 \< 92% by pulse oximetry.

Target for oxygenation in both arms is SpO2 between 92% and 95%. SpO2 \>95% without oxygen supply is acceptable. On the contrary, SpO2 \<92% may be acceptable when needed for medical reasons, mainly chronic hypercapnic patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-Flow nasal cannula (HFNC)

The patient will receive HFNC adjusted for SatO2 \> 92% and with, at least, 30 liters of total flow.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Conventional therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients \> 18 yr. with diagnostic criteria for severe sepsis, within 12 hours of admission in the Emergency Room, defined as hypotension after hemodynamic resuscitation, initial lactate \> 4, or persistence of organ dysfunction (oliguria \< 0.5 ml/kg/h, cyanosis, or altered consciousness).(qSOFA 1, 2 or 3)

Exclusion Criteria

* Patients who require immediate ventilatory support both invasive and non-invasive, defined by severe hypoxemia (PaO2/FiO2 \< 150), severe tachypnea (40 x') with signs of respiratory fatigue or low level of consciousness (Glasgow \< 8).
* Patients with limitation of the therapeutic effort or orders of not CPR.
* Patients not susceptible to treatment with HFNC (facial trauma, tracheostomized, rejection of previous treatments with HFNC).
* Participation in other clinical trials that may affect survival.
* Home treatment with oxygen, CPAP or Non-invasive ventilation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No