Nasal High Flow at Acute Hart Failure

NCT02058810 | Terminated

• 1 other identifier: 300513
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Heartfailure; Cardio-renal Syndrom

Keywords

nasal high flow oxygen; cardio-renal syndrom; heartfailure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of dyspnea

  3h, 6h, 24h

Other Outcomes (1)

• 90-day mortality

  90 days

Study Arms (2)

Conventional nasal Oxygen

OTHER

Conventional nasal Oxygen as needed

Device: Conventional nasal oxygen

Nasal high flow

OTHER

Nasal high flow therapy with FiO2 40% and flow of 40l/min for at least 48h

Device: Nasal high flow

Interventions

Nasal high flow DEVICE

Also known as: Optiflow, Fisher & Paykel Healthcare, RT202

Nasal high flow

Conventional nasal oxygen DEVICE

Also known as: nasal oxygen

Conventional nasal Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with acute heartfailure NYHA III und IV

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Regensburg: lead
• University of Magdeburg: collaborator

Study Sites (1)

UHMagdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: September 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

DE (1)