Nasal High Flow at Acute Hart Failure

NCT ID: NCT02058810

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-05-31

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

Conditions

Decompensated Heartfailure; Cardio-renal Syndrom

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional nasal Oxygen

Conventional nasal Oxygen as needed

Group Type: OTHER

Conventional nasal oxygen

Intervention Type: DEVICE

Nasal high flow

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

Group Type: OTHER

Nasal high flow

Intervention Type: DEVICE

Interventions

Nasal high flow

Intervention Type: DEVICE

Conventional nasal oxygen

Intervention Type: DEVICE

Other Intervention Names

Optiflow; Fisher & Paykel Healthcare; RT202; nasal oxygen

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Magdeburg

OTHER

Sponsor Role: collaborator

University Hospital Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Maximilian Malfertheiner

Dr. med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UHMagdeburg

Magdeburg, Saxony-Anhalt, Germany

Countries

Germany

Other Identifiers

300513

Identifier Type: -

Identifier Source: org_study_id