Clinical trial NCT02058810: Nasal High Flow at Acute Hart Failure
Official title: Does the Use of Optiflow High Flow Oxygen on Patients With Acute Cardial Decompensation (NYHA Classification Stage III-IV) Allow for Quicker Improvement of the Organ Dysfunction Than Conventional Standard-Oxygen-Insufflation-Therapy?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Decompensated Heartfailure
Cardio-renal Syndrom
Keywords: nasal high flow oxygen
cardio-renal syndrom
heartfailure
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
Collaborators: name: University of Magdeburg
First posted: 2014-02-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pilot study aims to compare the results of using a new respirator (OPTIFLOW TM-High-Flow-Machine) with those from Standard-Oxygen-Therapy during the stabilization of patients who have been hospitalized due to acute heart failure. We expect a faster and more effective stabilization after acute cardial decompensation among the patients with the High-Flow-machine.

The study should show whether the use of High-Flow-Therapy leads to a relevant improvement in terms of objective clinical parameters of heart failure like those for cardial-renal syndrome, changes in the nt-pro-BNP, weight loss, changes in the diameter of the inferior vena cava, in terms of the degree of shortness of breath and decompensation, and whether subjective clinical symptoms like dyspnea and quality of life differ between the two groups of patients.

The investigators see the primary outcome of the study as the improvement of the cardial-renal syndrome as a sign of the more effective stabilisation compared to the standard therapy. Furthermore, the investigators expect a quicker decrease in serum creatinine and an improvement in the creatinine clearance through therapy with the High-Flow-Machine. In terms of secondary outcomes of the study, the investigators are interested in also comparing e.g., the duration of hospital stays, 90-day mortality, and rehospitalisation within three months. Here, the investigators expect a quicker improvement in the subjective shortness of breath of the patients who are treated using the Hifh-Flow-Machine. Moreover, we believe that along with the individual subjective improvements (quality of life survey), the patients will experience a quicker release from the hospital and in this way, lead to a healthcare economic improvement among patients with repeated hospitalizations who usually have chronic problems.

It is also of great interest to us, whether the biomarker BNP is an appropriate parameter for determining the faster stabilization of the patient and whether the degree of improvement of subjective dyspnea is correlated with the time needed until the patient has been stabilised.

Detailed description: Primary endpoint:

Improvement of the cardiorenal syndrome type1 measured by the improvement of creatine clearance and the Serum-Creatinin of patients undergoing High-Flow treatment.

Secondary endpoints:

Worsening of cardiac insufficiency (application of catecholamines, need of NIV, intubation, death) Duration of hospital stay (in days) 90-day mortality Readmittance to hospital within 3 months Intrathoracic bloodvolume at hospital discharge Change of dyspnea at 3h, 6h, 24h \> VAS-0-100 (visual analog scale) Change in the diameter of the IVC (inferior vena cava) as a non-invasive parameter for assessing the degree of decompensation Change in the BNP (hospital admission vs. discharge, after 3 months) Weight loss in hospital Amount of diuretics

Eligibility criteria: Inclusion Criteria:

* patients with acute heartfailure NYHA III und IV

Exclusion Criteria:

* Patients wit respiratory insufficency and indication for mechanical ventilation
* Asthma bronchiale
* severe COPD
* cardiogenic shock (RR persisting\< 90mmHg systolic or catecholamine application)
* renal dialysis

Primary outcomes:
measure: Cardiorenal syndrome type 1
timeFrame: 3 Months
Secondary outcomes:
measure: Change of dyspnea
timeFrame: 3h, 6h, 24h
Other outcomes:
measure: 90-day mortality
timeFrame: 90 days
Locations:
city: Magdeburg
country: Germany
facility: UHMagdeburg
state: Sachsen Anhalt
Study officials:
References: