Back to resultsEvaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery
Primary Purpose
Heart Failure，Congestive
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
standard care
Nurse-based care
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure，Congestive
Eligibility Criteria
Inclusion Criteria:
patients with heart failure NYHA >= II (HFrEF and HFpEF) or LVEF <= 40% non-cardiac surgery planned later than 24 hours age > 18 years written informed consent
Exclusion Criteria:
patients on intensive care life-expectancy < 3 months
Sites / Locations
- Goethe University Hospital
- Klinikum Goethe UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
standard care
nurse-based care
Arm Description
responsible surgeon has actively to ask for cardiology support (he decides whether a heart failure specialist should see the patient post-operatively)
heart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition
Outcomes
Primary Outcome Measures
composite endpoint of in-hospital heart failure-related complications (readmission on ICU, re-initiation of inotropic support, pleural effusion, pulmonary edema, pneumonia requiring antibiotic treatment, non-invasive or invasive ventilation)
severe heart-failure related clinical events during hospitalisation for non-cardiac surgery
Secondary Outcome Measures
days in hospital
total days in hospital for non-cardiac surgery
acute kidney injury
Acute kidney injury grade: 0 = Creatinine increase < 1,5 x baseline, Stage 1 Creatinine increase > 1,5 x baseline, Stage 2 Creatinine increase > 2 x baseline, Stage 3 Creatinine increase > 3 x baseline)
Qulity of Life by SF-12
repetitive assessment with SF-12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03202329
Brief Title
Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery
Official Title
Evaluation of Post-operative, Nurse-based Heart Failure Care Compared to Standard Treatment in Patients With Heart Failure Undergoing Non-cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Birgit Assmus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure，Congestive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
525 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard care
Arm Type
Other
Arm Description
responsible surgeon has actively to ask for cardiology support (he decides whether a heart failure specialist should see the patient post-operatively)
Arm Title
nurse-based care
Arm Type
Other
Arm Description
heart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon
Intervention Type
Other
Intervention Name(s)
Nurse-based care
Intervention Description
board-certified heart failure nurses provide heart failure guidance post-operatively on every working day
Primary Outcome Measure Information:
Title
composite endpoint of in-hospital heart failure-related complications (readmission on ICU, re-initiation of inotropic support, pleural effusion, pulmonary edema, pneumonia requiring antibiotic treatment, non-invasive or invasive ventilation)
Description
severe heart-failure related clinical events during hospitalisation for non-cardiac surgery
Time Frame
30 days
Secondary Outcome Measure Information:
Title
days in hospital
Description
total days in hospital for non-cardiac surgery
Time Frame
90 days
Title
acute kidney injury
Description
Acute kidney injury grade: 0 = Creatinine increase < 1,5 x baseline, Stage 1 Creatinine increase > 1,5 x baseline, Stage 2 Creatinine increase > 2 x baseline, Stage 3 Creatinine increase > 3 x baseline)
Time Frame
90 days
Title
Qulity of Life by SF-12
Description
repetitive assessment with SF-12
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 heart failure NYHA >= II (HFrEF and HFpEF) or LVEF <= 40% non-cardiac surgery planned later than 24 hours age > 18 years written informed consent
Exclusion Criteria:
patients on intensive care life-expectancy < 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgit Assmus, MD
Phone
+49696301
Ext
5789
Email
birgit.assmus@kgu.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas M Zeiher, MD
Phone
+49696301
Ext
84690
Email
zeiher@em.uni-frankfurt.de
Facility Information:
Facility Name
Goethe University Hospital
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Enrolling by invitation
Facility Name
Klinikum Goethe University
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgit Assmus, MD
Phone
+49 69 6301
Ext
84690
Email
birgit.assmus@kgu.de
First Name & Middle Initial & Last Name & Degree
Andreas Ecke, MD
Phone
+49 69 6301
Ext
84690
Email
andreas.ecke@kgu.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery
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