Patients with elevated NT-proBNP as a sign of left ventricular dysfunction undergoing hipfracturesurgery. MedDRA version: 12.1 Level: PT Classification code 10020100 Term: Hip fracture MedDRA version: 12.1 Level: HLT Classification code 10019283 Term: Heart failure signs and symptoms
Conditions
Interventions
Trade Name: Voluven
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: voluven
CAS Number: 9005-27-0
Current Sponsor code: voluven
Other descriptive name: HETASTARCH
Concentration unit: mg
Sponsors
Department of Anesthesiology & Intensive Care
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusions Criteria: 1. Patients >= 65 yrs 2. Proximal femur fracture where the patient is planned to be operated during the day (Monday-Friday). 3. NT-proBNP > 900 ng/l in patients 65-75 yrs old, and >1800 ng/l in patients > 75 yrs. 4. Informed consent provided by the patient. All of the above criteria must be fulfilled before the patient can be included in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusions Criteria: 1. Informed consent cannot be provided 2. Mental or verbal difficulty in understanding or expressing willingness to participate in the study. 3. Instable angina pectoris. 4. Ongoing myocardial infarct or ischemia 5. Circulatory shock 6. Decompensated cardiac failure or pulmonary oedema 7. Pathologic femur fracture 8. Chronic haemodialysis 9. Cardiac valve incompetence that has haemodynamic consequences Any one of the above is a criterion for exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hypotesis Our hypothesis is that perioperative mortality and cardiac complications can be reduced in this group of patients by preoperative optimization. Primary aim: Can preoperative optimization of patients with cardiac failure and increased NT-proBNP who are undergoing surgery for proximal hip fracture reduce the risk of perioperative cardiac complications? ;Secondary Objective: Secondary aim: Can preoperative optimization of patients with cardiac failure and increased NT-proBNP reduce postoperative length of hospital stay, 30-day morbidity or 3 months mortality?;Primary end point(s): Primary endpoints: Major cardiac complications: defined as myocardial injury (Troponin T = 0.04 µg/l and/or myocardial infarct or death from cardiac complications or therapy-requiring cardiac failure) | — |
Countries
Sweden
Outcome results
None listed