Nasal High Flow at Acute Hart Failure

Not Applicable

Terminated

• Conditions: Cardio-renal Syndrom; Decompensated Heartfailure
• Interventions: Device: Nasal high flow; Device: Conventional nasal oxygen

• Registration Number: NCT02058810
• Lead Sponsor: University Hospital Regensburg

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• patients with acute heartfailure NYHA III und IV

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal high flow	Nasal high flow	Nasal high flow therapy with FiO2 40% and flow of 40l/min for at least 48h
Conventional nasal Oxygen	Conventional nasal oxygen	Conventional nasal Oxygen as needed

Primary Outcome Measures

Name	Time	Method
Cardiorenal syndrome type 1	3 Months	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 \[5\].

Secondary Outcome Measures

Name	Time	Method
Change of dyspnea	3h, 6h, 24h	Change of dyspnea at 3h, 6h, 24h \> VAS-0-100 (visual analog scale)

Trial Locations

Locations (1)

UHMagdeburg; 🇩🇪 Magdeburg, Sachsen Anhalt, Germany