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High Flow Nasal Cannula in Severe Sepsis (OPTISEPSIS)

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ClinicalTrials.gov Identifier: NCT03334227
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa

Brief Summary:
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 6 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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Device: High-Flow nasal cannula (HFNC) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 592 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with severe sepsis will be randomized to recieve conventional oxygenotherapy if needed or high flow nasal cannula.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Flow Nasal Cannula Therapy as an Adjuvant in the Treatment of Severe Sepsis. A Multicenter Parallel-group Randomized Clinical Trial
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: 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.

Device: High-Flow nasal cannula (HFNC)
The patient will receive HFNC adjusted for SatO2 > 92% and with, at least, 30 liters of total flow.
Other Name: Conventional therapy

No Intervention: 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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: 60 day ]
    60-day survival after enrollment


Secondary Outcome Measures :
  1. Mechanical ventilation support [ Time Frame: up to 60-days ]
    Institution of mechanical ventilation (either invasive or noninvasive)

  2. Dialysis support [ Time Frame: up to 60-days ]
    Institution of dialysis

  3. Vasoactive drugs tappering [ Time Frame: up to 60-days ]
    Daily dose of vasoactive drugs until stopping

  4. Sequential Organ Failure Assessment [ Time Frame: up to 60-days ]
    Daily Sequential Organ Failure Assessment score. The organs scored are respiratory, cardiovascular, neurologic, hematologic, renal, and liver. Each organ is scored as 0 (best) to 4 (worse) and the total score is the sum of each component.

  5. Acidosis improvement [ Time Frame: up to 60-days ]
    Hours until the ph becomes normal

  6. Central Venous Oxygen Saturation (SatVO2) [ Time Frame: up to 60-days ]
    Hours until the SatVO2 < 65%

  7. Lactate clearance [ Time Frame: up to 60-days ]
    Hours until lactate < 3 mmol/l



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 yr. with diagnostic criteria for severe sepsis, within 6 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334227


Contacts
Contact: Rafael Fernandez, PhD +34619835178 rfernandezf@althaia.cat

Locations
Spain
ICU. Fundacio Althaia Recruiting
Manresa, Barcelona, Spain, 08242
Contact: Rafael Fernandez, MD    34.938732112 ext 3216    rfernandezf@althaia.cat   
Principal Investigator: Rafael Fernandez, MD         
Sub-Investigator: Carles Subira, MD         
Sponsors and Collaborators
Althaia Xarxa Assistencial Universitària de Manresa
Investigators
Principal Investigator: Rafael Fernandez, PhD Fundacio Althaia

Publications of Results:

Responsible Party: Rafael Fernandez, Director. Critical Care Department, Althaia Xarxa Assistencial Universitària de Manresa
ClinicalTrials.gov Identifier: NCT03334227     History of Changes
Other Study ID Numbers: CEI17/54
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa:
High-Flow Nasal Cannula
Severe Sepsis
qSOFA

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes