Nasal High Flow at Acute Hart Failure

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?

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.

Study Overview

• Status: Terminated
• Conditions: Decompensated Heartfailure; Cardio-renal Syndrom
• Intervention / Treatment: Device: Conventional nasal oxygen; Device: Nasal high flow

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

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Sachsen Anhalt
    • Magdeburg, Sachsen Anhalt, Germany, 39120
      • UHMagdeburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional nasal Oxygen; Conventional nasal Oxygen as needed	Device: Conventional nasal oxygen; Other Names: nasal oxygen
Other: Nasal high flow; Nasal high flow therapy with FiO2 40% and flow of 40l/min for at least 48h	Device: Nasal high flow; Other Names: Optiflow; Fisher & Paykel Healthcare; RT202

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorenal syndrome type 1	The acute deterioration of the cardial situation often leads to a consecutive deterioration of renal function. The damage to renal function caused by acute cardial genesis is defined as cardiorenal syndrome type 1 [2]. In such cases, the venous congestion with heightened central venous pressure leads to disruption of renalfunction and possibly even to acute kidney failure [3, 4]. This is defined as cardiorenal syndrom with an increase in serumcreatine of >0,3 mg/dl and is associated with higher mortality and longer hospital stays [5].	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of dyspnea	Change of dyspnea at 3h, 6h, 24h > VAS-0-100 (visual analog scale)	3h, 6h, 24h

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality	Mortality after 90 days	90 days

Collaborators and Investigators

• Sponsor: University Hospital Regensburg
• Collaborators: University of Magdeburg

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: nasal high flow oxygen; cardio-renal syndrom; heartfailure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 300513