Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery
1 other identifier
interventional
525
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJuly 28, 2020
July 1, 2020
3.2 years
June 27, 2017
July 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
30 days
Secondary Outcomes (3)
days in hospital
90 days
acute kidney injury
90 days
Qulity of Life by SF-12
90 days
Study Arms (2)
standard care
OTHERresponsible surgeon has actively to ask for cardiology support (he decides whether a heart failure specialist should see the patient post-operatively)
nurse-based care
OTHERheart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition
Interventions
cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon
board-certified heart failure nurses provide heart failure guidance post-operatively on every working day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patients on intensive care life-expectancy \< 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Birgit Assmuslead
Study Sites (2)
Goethe University Hospital
Frankfurt am Main, Hesse, 60590, Germany
Klinikum Goethe University
Frankfurt am Main, 60590, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
June 27, 2017
First Posted
June 28, 2017
Study Start
October 1, 2017
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
July 28, 2020
Record last verified: 2020-07