Nasal High Flow at Acute Hart Failure
Primary Purpose
Decompensated Heartfailure, Cardio-renal Syndrom
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nasal high flow
Conventional nasal oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Decompensated Heartfailure focused on measuring nasal high flow oxygen, cardio-renal syndrom, heartfailure
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
Sites / Locations
- UHMagdeburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Conventional nasal Oxygen
Nasal high flow
Arm Description
Conventional nasal Oxygen as needed
Nasal high flow therapy with FiO2 40% and flow of 40l/min for at least 48h
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
Change of dyspnea
Change of dyspnea at 3h, 6h, 24h > VAS-0-100 (visual analog scale)
Full Information
NCT ID
NCT02058810
First Posted
February 6, 2014
Last Updated
September 24, 2019
Sponsor
University Hospital Regensburg
Collaborators
University of Magdeburg
1. Study Identification
Unique Protocol Identification Number
NCT02058810
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients, PI left
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Regensburg
Collaborators
University of Magdeburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Heartfailure, Cardio-renal Syndrom
Keywords
nasal high flow oxygen, cardio-renal syndrom, heartfailure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional nasal Oxygen
Arm Type
Other
Arm Description
Conventional nasal Oxygen as needed
Arm Title
Nasal high flow
Arm Type
Other
Arm Description
Nasal high flow therapy with FiO2 40% and flow of 40l/min for at least 48h
Intervention Type
Device
Intervention Name(s)
Nasal high flow
Other Intervention Name(s)
Optiflow, Fisher & Paykel Healthcare, RT202
Intervention Type
Device
Intervention Name(s)
Conventional nasal oxygen
Other Intervention Name(s)
nasal oxygen
Primary Outcome Measure Information:
Title
Cardiorenal syndrome type 1
Description
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].
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Change of dyspnea
Description
Change of dyspnea at 3h, 6h, 24h > VAS-0-100 (visual analog scale)
Time Frame
3h, 6h, 24h
Other Pre-specified Outcome Measures:
Title
90-day mortality
Description
Mortality after 90 days
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UHMagdeburg
City
Magdeburg
State/Province
Sachsen Anhalt
ZIP/Postal Code
39120
Country
Germany
12. IPD Sharing Statement
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Nasal High Flow at Acute Hart Failure
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