High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

University of Alberta1 site in 1 country50 target enrollmentJanuary 2017

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: University of Alberta
Enrollment: 50
Locations: 1
Primary Endpoint: Change in NT-proBNP from baseline to 72 hours
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this pilot trial is to determine whether inpatients presenting to the Emergency Department (ED) with symptoms suggestive of Acute Heart Failure (AHF), who receive supplemental oxygen adjusted at either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen saturation level, leads to greater reduction in N-terminal-proBNP (NT-proBNP) at 72 hours.

Detailed Description

Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

July 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Alberta

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\>40 years of age presenting to the ED with AHF
•objective finding of HF (BNP \>400 pg/ml or Chest X-Ray with pulmonary congestion)
•plan to admit with primary diagnosis as HF
•must be able to be randomized within 16 hours of presenting to the ED
•provided written informed consent

Exclusion Criteria

•on home oxygen
•known prior hypercapnic failure (PaCO2 \>50 mmHg)
•primary pulmonary hypertension,
•patients who require urgent positive pressure ventilation or intubation
•patients on \>10 L/min oxygen

Outcomes

Primary Outcomes

Change in NT-proBNP from baseline to 72 hours

Time Frame: 72 hours

Secondary Outcomes

Hochberg endpoint (combination of NT-proBNP and PGA)(72 hours)
Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)(72 hours)
Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours(72 hours)
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours(72 hours)
30-day clinical events(30 days)
Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization(30 days)
Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours(72 hours)
Number of worsening heart failure (WHF) events(7 days)