High Flow Nasal Cannula in Severe Sepsis (OPTISEPSIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03334227|
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : January 16, 2018
|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|
|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)|
|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|
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.
- Mortality [ Time Frame: 60 day ]60-day survival after enrollment
- Mechanical ventilation support [ Time Frame: up to 60-days ]Institution of mechanical ventilation (either invasive or noninvasive)
- Dialysis support [ Time Frame: up to 60-days ]Institution of dialysis
- Vasoactive drugs tappering [ Time Frame: up to 60-days ]Daily dose of vasoactive drugs until stopping
- 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.
- Acidosis improvement [ Time Frame: up to 60-days ]Hours until the ph becomes normal
- Central Venous Oxygen Saturation (SatVO2) [ Time Frame: up to 60-days ]Hours until the SatVO2 < 65%
- Lactate clearance [ Time Frame: up to 60-days ]Hours until lactate < 3 mmol/l
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
|Contact: Rafael Fernandez, PhDfirstname.lastname@example.org|
|ICU. Fundacio Althaia||Recruiting|
|Manresa, Barcelona, Spain, 08242|
|Contact: Rafael Fernandez, MD 34.938732112 ext 3216 email@example.com|
|Principal Investigator: Rafael Fernandez, MD|
|Sub-Investigator: Carles Subira, MD|
|Principal Investigator:||Rafael Fernandez, PhD||Fundacio Althaia|