Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery

Not Applicable

• Conditions: Heart Failure，Congestive
• Interventions: Other: standard care; Other: Nurse-based care

• Registration Number: NCT03202329
• Lead Sponsor: Birgit Assmus

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2017-10-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 525

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care	standard care	responsible surgeon has actively to ask for cardiology support (he decides whether a heart failure specialist should see the patient post-operatively)
nurse-based care	Nurse-based care	heart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition

Primary Outcome Measures

Name	Time	Method
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)	30 days	severe heart-failure related clinical events during hospitalisation for non-cardiac surgery

Secondary Outcome Measures

Name	Time	Method
days in hospital	90 days	total days in hospital for non-cardiac surgery
Qulity of Life by SF-12	90 days	repetitive assessment with SF-12
acute kidney injury	90 days	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)

Trial Locations

Locations (2)

Goethe University Hospital; 🇩🇪 Frankfurt, Hessen, Germany

Klinikum Goethe University; 🇩🇪 Frankfurt am Main, Germany